CN108463323B

CN108463323B - Adjustable lens with cavity

Info

Publication number: CN108463323B
Application number: CN201680078589.4A
Authority: CN
Inventors: 亚当·哈兰特; 阿梅利亚·达文波特; 尼尔·克拉默; 阿米塔瓦·古普塔; 威廉姆·J·林克; 加米尔·阿尔哈基米; 史蒂夫·韦特; 利萨·斯塔德尼基; 穆萨·阿尔哈基米
Original assignee: ONEFOCUS VISION Inc
Current assignee: ONEFOCUS VISION Inc
Priority date: 2015-11-11
Filing date: 2016-11-11
Publication date: 2020-10-13
Anticipated expiration: 2036-11-11
Also published as: EP3374143A4; EP3374143A1; US20200409176A1; US20170371180A1; WO2017083774A1; US20180173010A1; EP3374143B1; US10761348B2; CN108463323A; US9910296B2; JP2019505010A

Abstract

The lens includes a lumen structure formed by dissolving a soluble insert material. The inner soluble material can be dissolved through a lens body, such as a contact lens, to form a cavity within the contact lens. The cavity within the lens can be shaped in many ways and corresponds to the shape of the dissolved material so that many internal cavity shapes can be easily manufactured within the contact lens. The insert may be placed in a mold with a pre-polymer material and the pre-polymer material cured with the insert placed in the mold to form the lens body. The polymerized polymer may include a low expansion polymer to inhibit expansion of the lens upon hydration. When hydrated, the polymer may comprise a hydrogel. The soft contact lens material contains sufficient cross-linking to provide structure to the lens and shape the cavity.

Description

Adjustable lens with cavity

Cross-referencing

This PCT application claims priority to U.S. provisional application serial No. 62/327,938 entitled "accmod ification LENS WITHCAVITY" filed on 26/4/2016 and U.S. provisional application serial No. 62/254,093 entitled "accmod ification LENS WITH CAVITY" filed on 11/2015, the entire disclosures of which are incorporated herein by reference.

The subject matter of the present application relates to the following patent applications: PCT/US2014/013427 entitled "AccomolatingSoft Contact lenses" filed on 28.1.2014; PCT/US2014/013859 entitled "manufacturing Process of an adapting Contact Lens", filed 30/1/2014; PCT/US2014/071988 entitled "fluid Module For accessing Soft Contact Lens" filed on 12/22 of 2014; U.S. application Ser. No. 62/031,324 entitled "Sacrificial moving Process for and accessing Contact Lens", filed on 31/7/2014; PCT/US2015/0433307 entitled "LOWER LID ACTIVATING AN ELECTRONIC LENS" filed 31/7/2015; PCT/US2016/061696 entitled "SOFT CONTACT LENS MATERIAL WITH LOW VOLUMETRIC EXPANSION UPONHYDRATION" filed 11/2016; and PCT/US2016/061697 entitled "ROTATONAL SYSTEBILIZED CONTACT LENS" filed 11/2016; the entire disclosure of which is incorporated herein by reference.

The subject matter of the present application also relates to the following provisional patent applications: U.S. provisional application serial No. 62/254,048 entitled "soft contact LENS MATERIAL WITH LOW volume volatile extraction on update purity" filed 11/2015; U.S. provisional application serial No. 62/254,080 entitled "rotalinally static personnel LENS" filed 11/2015; and U.S. provisional application serial No. 62/255,242 entitled "rotavapor crystal CONTACT LENS" filed 11/13/2015; the entire disclosure of which is incorporated herein by reference.

Background

Existing methods and apparatus for shaping and manufacturing lenses, such as contact lenses, may be less than ideal in at least some respects. For example, contact lenses having internal fluidic structures such as chambers may be difficult to manufacture in at least some instances. While structures such as bubbles or modules may be embedded within the contact lens, such structures may complicate the manufacturing process to some extent more than is desirable.

There are two types of designs possible for multifocal contact lenses: designs providing simultaneous vision (Wooley et al USP7,517,084, USP7,322,695) and designs providing alternating vision (Evans et al USP7,503,652, USP 6,092,899, USP7,810,925). Both types of contact lenses may have at least two or more optical zones of different focal lengths. Multifocal contact lenses with optic zones of different focusing powers and disposed radially symmetrically about the optical center of the lens, which is also often the geometric center, can provide simultaneous vision. Alternating vision may be provided by a design in which the optical zones are generally spaced from each other along the vertical meridian such that the optical center of each zone is aligned with the pupil center as the lens translates upward during down gaze. Both of these approaches are not fully accepted by contact lens wearers and there is a continuing unmet need for an adjustable contact lens with a dynamically variable optical element having a single variable focal length that is easy to wear and use. The image quality provided by an adjustable contact lens that can be easily adjusted by the wearer may be much better than a multifocal lens.

Existing contact lens designs have been described by Iuliano (USP 7,699,464B 2). The manufacture of such devices may be more complex than is desirable. Earlier, ellie disclosed an adjustable contact lens (WO1991010154a 1).

Adjustable contact lenses have been proposed in which the central chamber increases in curvature when the eyelid engages the lower chamber coupled to the central chamber. Existing lenses may have less than ideal optical performance and may be more difficult to use and manufacture than ideal. In some cases, existing contact lenses may provide a less than ideal response to eyelid pressure and may not change shape as easily as desired in response to eyelid pressure. Also, portions of the lens may be shaped in stages and different segments brought together to shape the lens, which results in additional steps in the manufacturing process. While modules embedded in adjustable contact lenses may be effective, such modules may result in greater complexity and cost than is desirable. Moreover, the embedded modules may provide a non-ideal amount of resistance to movement of the structure of the adjustable contact lens, which is dependent on the stiffness of the tensile modulus of the film comprising the module.

In view of the above, there is a need for improved contact lenses and methods of manufacture. Ideally, such a contact lens and method of manufacture would provide a contact lens that changes shape as the amount of pressure is reduced, involve fewer steps, and allow for the production of contact lenses having a lumen structure in large quantities.

Disclosure of Invention

Although reference is made to an accommodating contact lens, the lenses, methods and devices disclosed herein may be used with many lenses (e.g., intraocular lenses) and accommodating intraocular lenses. Materials having a cavity as described herein will have many applications in many fields, such as implants for sensors and drug delivery. The cavity may be formed in a body comprising a polymeric material that allows the contents of the cavity to be in equilibrium with an external solution prior to use and may allow fluid exchange between the cavity and an external liquid when placed on a subject.

The lens includes a lumen structure formed by dissolving a soluble insert material. The soluble material of the interior can dissolve through a lens body, such as a contact lens, to form a cavity within the contact lens. The cavity within the lens can be shaped in many ways and corresponds to the shape of the dissolved material so that many internal cavity shapes can be easily manufactured within the contact lens. The insert may be placed in a mold with a pre-polymer material and the pre-polymer material cured with the insert placed in the mold to form the lens body. The polymerized polymer may include a low expansion polymer to inhibit expansion of the lens upon hydration. The polymeric material may be hydrated and the insert dissolved to form a cavity having a desired shape within the lens body. When hydrated, the polymer may comprise a hydrogel. The soft contact lens material contains a sufficient amount of cross-linking to provide structure to the lens and to form a cavity and allow diffusion of water and solutes into and out of the cavity to establish equilibrium of the cavity with the environment outside the lens body. The insert has a molecular weight low enough to diffuse out of the lens body upon hydration and high enough to provide strength to the insert for handling and placement in a lens mold. Diffusion of the dissolved insert material out of the cavity as the material dissolves may inhibit osmotic pressure and expansion of the cavity such that the structural integrity of the contact lens and the cavity may be maintained. After dissolution of the insert, the shape of the cavity corresponds to the three-dimensional shape profile of the insert material, such that the cavity can be shaped in a variety of ways.

The inner chamber may include an inner optical chamber and a lower chamber of the adjustable contact lens with a channel extending therebetween. When the lower eyelid engages the lower chamber, fluid is delivered to the optical chamber to increase the curvature of the optical chamber and provide optical power for near vision.

The chamber of the contact lens can be configured in many ways. The chamber may release water through the lens body to the eye to moisturize the eye, thereby providing hydration to the eye. The chamber may contain a drug for treating the eye, and the drug may be released from the chamber through the lens body to treat the eye. A cavity may be formed over at least a portion of the sensor embedded within the contact lens to improve coupling of the sensor to the external environment of the lens.

The contact lens may be provided with a sterile package, wherein a sterile fluid is contained in the sterile package and the contact lens is immersed in the fluid. The cavity of the contact lens may be in equilibrium with the fluid in which the contact lens is immersed.

In a first aspect, a soft contact lens for correcting vision of an eye is provided. Soft contact lenses include a hydrogel contact lens body comprising water and a crosslinked polymer. The contact lens body defines an internal cavity containing a fluid. The crosslinked polymer allows water to diffuse into and out of the contact lens body so as to diffuse from the outer surface of the body into the cavity. The cavity is shaped to correct vision when in equilibrium with the tear fluid of the eye.

In many embodiments, the hydrogel contact lens body and the cavity can be configured together to increase optical power by at least 2D with an increase in internal pressure of about 20 pascals (Pa) to about 50 pascals (Pa). The cavity may comprise a volume of about 0.5mm³To about 5mm³The volume of fluid within the range. The hydrogel contact lens body can comprise a modulus in the range of about 0.25MPa to about 2 MPa. The hydrogel material of the contact lens body may comprise an equilibrium water content in the range of about 30% to about 70%.

In many embodiments, the hydrogel contact lens body can include an inner surface defining a cavity. The inner surface may include an internal surface structure defined by erosion of material from within the cavity.

In many embodiments, the hydrogel contact lens body can include a first portion on a first side of the cavity and a second portion on a second side of the cavity with the cavity extending therebetween, the first portion being bonded to the second portion distal from the cavity to contain a fluid within the cavity. The interface of the first material bound to the second material may optionally be detected by dark field microscopy.

In many embodiments, the crosslinked polymer may be in direct contact with the liquid of the cavity.

In many embodiments, the polymer may include sufficient rigidity to retain the shape of the insert dissolved from within the lens body, thereby forming a cavity.

In many embodiments, the cavity may contain a dissolved material having a molecular weight of about 3k to 7k daltons. The dissolved material may be capable of diffusing through the polymer of the contact lens body. The dissolved material may also include a material that dissolves to form the insert of the cavity. The cavity may include a shape profile corresponding to the dissolved insert.

In many embodiments, the chamber may include an optical portion configured to correct vision of the eye and a lower portion fluidly coupled to the optical portion. The optical portion may be configured to provide near vision correction when the eyelid engages the lower portion. The polymer may include a sufficient amount of cross-linking to retain the fluid in the optical portion when the lower portion engages the eyelid to correct near vision of the eye. Alternatively or in combination, the contact lens body may comprise one or more articulating portions coupled to the optical portion and the lower portion.

In many embodiments, the cavity may include one or more internal structures formed from an erodable material.

In many embodiments, the polymer may comprise a hydrogel.

In many embodiments, the cavity may be filled with a liquid and not hermetically sealed. The contact lens body may be permeable to the fluid encapsulating the lens, and the cavity may be in equilibrium with the fluid.

In many embodiments, the polymer may comprise a homogeneous polymer.

In many embodiments, the polymer may comprise a homopolymer.

In many embodiments, the polymer may comprise a hydrogel.

In many embodiments, the polymer can include channels sized to allow water to diffuse between the cavity and the exterior of the lens body and inhibit bacteria from entering the cavity from the exterior of the lens body.

In many embodiments, the polymer may allow molecules having a radius of gyration of no more than 50nm to diffuse through the polymer of the lens body. The polymer may allow molecules having a radius of gyration of no more than 15nm to diffuse through the polymer of the lens body.

In many embodiments, the cavity may contain a dissolved material having a molecular weight of about 3k to 10k daltons. The dissolved material may be capable of diffusing through the polymer of the contact lens body.

In many embodiments, the cavity may comprise a volume of about 1 μ or up to 5 μ L.

In many embodiments, the contact fluid may comprise an index of refraction in the range of about 1.31 to about 1.37, and the contact lens body may comprise an index of refraction in the range of about 1.37 to about 1.48.

In many embodiments, the hydrogel contact lens can have an anterior side with an anterior thickness defined between the anterior surface of the contact lens body and the anterior surface of the lumen. The hydrogel contact lens can have a posterior side having a posterior thickness defined between a posterior surface of the contact lens body and a posterior surface of the lumen. The front thickness may be less than the back thickness. The front thickness may be within a range defined between any two of the following values: about 10 microns, about 25 microns, about 50 microns, about 100 microns, about 150 microns, and 200 microns. The back thickness may be in a range defined between any two of the following values: about 10 microns, about 100 microns, and about 200 microns. The thickness of the lumen from its front surface to its rear surface may be within a range defined between any two of the following values: about 0.5 microns, about 15 microns, about 50 microns, and about 100 microns. The thickness of the contact lens body from its anterior surface to its posterior surface may range from about 80 microns to about 250 microns.

In many embodiments, the shape-changing portion of the lens for correcting vision when placed on the eye can have an RMS optical path difference aberration (RMS optical path difference) of about 0.4 microns or less in the distance vision configuration.

In many embodiments, the inner surface of the polymer defining the cavity includes a shape profile corresponding to the solid material dissolved to form the cavity. The interior surface of the polymer defining the cavity may also include a structure corresponding to a solid material dissolved to form the cavity. Alternatively or in combination, the inner surface of the cavity comprises an optically smooth surface through which light passes over the interior portion of the cavity to correct vision. The optically smooth surface can have a wavefront distortion of about 0.3 microns or less as measured through the optically smooth surface. The optically smooth surface may not include visually perceptible artifacts when worn by the patient. The optically smooth surface may have an RMS value of about 0.2 microns or less. The interior surface of the cavity may include residual surface structures from the solid material that dissolved to form the cavity. The inner surface of the cavity may have an RMS value of about 50nm or less. The inner surface of the cavity may have an RMS value in a range defined between any two of the following values: about 5nm, about 10nm, about 15nm, about 300nm, about 500nm and about 1000 nm.

In another aspect, a soft contact lens package is provided. Soft contact lens packages include sterile packages containing an aqueous fluid and a soft contact lens. A soft contact lens includes a contact lens body. The contact lens body includes a hydrogel material contained within a package. The contact lens body is immersed in a fluid contained within the package. The contact lens body defines a cavity within the body, the cavity containing a liquid. The contact lens body may be permeable to the liquid and the fluid in which the contact lens is immersed, such that the cavity is in equilibrium with the fluid outside the lens body.

In many embodiments, at least a portion of the fluid may have diffused into the cavity.

In many embodiments, the contact lens body may be permeable to water such that when placed on the eye, the contact lens wets the eye with fluid from the lumen.

In many embodiments, the contact lens body can include an index of refraction in the range of about 1.31 to about 1.37. The contact lens body may include an index of refraction in a range of about 1.37 to about 1.48. The fluid may include an index of refraction in a range of about 1.31 to about 1.37.

In many embodiments, the contact lens body can include an amount of cross-linking sufficient to inhibit bacteria from entering the cavity from outside the contact lens body.

In another aspect, an adjustable soft contact lens is provided. The lens includes an embedded cavity filled with a hydration fluid (hydration) of the lens.

In many embodiments, the lens may generate positive power on the eye when looking down at a near object. The positive power may range from 0.5D to 6.0D. Alternatively or in combination, the downward gaze may be in the range of 10 to 40 degrees. Alternatively or in combination, the object distance may be in the range of 15cm to 200 cm.

In many embodiments, the lens may include a crosslinked hydrogel network formed from a photopolymerizable prepolymer formulation. The hydrogel may have an amount of water in the range of about 28% to 65%.

In many embodiments, the cavity may contain a drug.

In many embodiments, the cavity may contain timolol.

In many embodiments, the lens may also include a sensor. At least a portion of the sensor may be located within the cavity.

In many embodiments, the lens may also include a sensor. At least a portion of the sensor may be located within the cavity. The sensor may include one or more of a pressure sensor, a glucose sensor, a biomarker sensor, an electrical sensor, or a sensor having ion-specific microelectrodes. The sensor may comprise no more than about 0.001mm³The volume of (a).

In another aspect, a method of manufacturing a lens is provided. The method includes dissolving an insert from within a polymeric lens material to form a cavity within the polymeric lens material. In many embodiments, the method further comprises polymerizing the pre-polymer material to form a polymeric material and hydrating the polymeric lens material with the insert contained therein.

In many embodiments, the prepolymer material can be polymerized by light.

In many embodiments, the method may further comprise placing the insert and the prepolymer material to cure together with the insert placed in the mold.

In many embodiments, the insert may comprise a biocompatible water-soluble polymer. The biocompatible water-soluble polymer may include one or more of the following: polyvinyl alcohol, polyvinyl acetate, polyethylene oxide, propylene oxide, copolymers of ethylene and propylene oxide (pluronic acid), polyvinylpyrrolidone, polyethyleneimine, polyacrylamide or polysaccharides.

In many embodiments, the insert may comprise a biocompatible water-soluble polymer. The biocompatible water-soluble polymer may include one or more of the following: polyvinyl alcohol, polyvinyl acetate, polyethylene oxide, propylene oxide, copolymers of ethylene oxide and propylene oxide (pluronic acid), polyvinylpyrrolidone, polyethyleneimine, polyacrylamide, polysaccharides, polyethylene glycol (PEG) in the molecular weight range of about 600g/mol to about 6000g/mol, hydrophilic ionic polyacrylates, polymethacrylates, or copolymers of hydrophilic ionic polyacrylates and polymethacrylates.

In many embodiments, the prepolymer may include one or more of a monomer or oligomer.

In many embodiments, the polymeric lens material may comprise a homopolymer.

In many embodiments, the polymeric lens material may include a low expansion polymer.

In many embodiments, the insert may comprise a substantially uniform thickness.

In many embodiments, the insert may include a substantially uniform thickness and curved upper and lower surfaces, the curvature of the surfaces corresponding to the curvature of a mold defining the curvature of the base of the contact lens.

In many embodiments, the insert may include a thickness and shape profile corresponding to the cavity.

In many embodiments, an insert may comprise a material having a molecular weight in a range of about 3 kilodaltons to about 10 kilodaltons, and wherein the material dissolves and diffuses through the polymeric lens material to form a cavity within the polymeric lens material.

In many embodiments, the insert may include a material having a molecular weight of at least about 3 kdaltons to add rigidity to the material to maintain shape. The cavity may correspond to the shape of the insert.

In many embodiments, the lens may include a crosslinked hydrogel network formed from a photopolymerizable prepolymer formulation. The hydrogel may comprise a hydration level in the range of about 28% to about 65%.

In another aspect, a soft contact lens for correcting vision of an eye is provided. Soft contact lenses include a hydrogel contact lens body comprising water and a crosslinked polymer. The contact lens body defines an internal cavity containing a fluid. The crosslinked polymer allows water to diffuse into and out of the contact lens body to diffuse from the outer surface of the body into the cavity. The contact lens body includes an anterior surface and a posterior surface. The posterior surface, anterior surface, and cavity are shaped to correct vision in the event that the cavity is in equilibrium with the tear fluid of the eye.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert includes an erodible material comprised of a first material configured to dissolve and pass through the channel of the hydrogel contact lens and a second material configured with one or more of a particle size or solubility to remain within the cavity formed by the dissolution of the first material.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert includes an erodible material comprised of a first material configured to dissolve and pass through the channel of the hydrogel contact lens, and a second material configured with one or more of a particle size or solubility to remain within the cavity formed by the dissolution of the first material. The amount of the second material is sufficient to provide an osmolality (osmolality) of the lumen in the range of about 200 milliosmoles (milliosmoles) to about 290 milliosmoles when the first material has passed through the passageway.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert includes an erodible material comprised of a first polymeric material configured to dissolve and pass through the channel of the hydrogel contact lens, and a second poorly soluble polymeric material configured to remain within the cavity formed by dissolving the first material. The first polymeric material comprises a water soluble material and the second polymeric material comprises a water insoluble material.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert includes an erodible material comprised of a first polymeric material comprising a first amount of acetate and configured to dissolve and pass through the channel of the hydrogel contact lens, and a second sparingly soluble polymeric material comprising a greater amount of acetate to remain within the cavity formed by the dissolution of the first material.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert includes an erodible material comprised of a first water-soluble polymeric material containing a first molecular weight and configured to dissolve and pass through the channel of the hydrogel contact lens, and a second poorly water-soluble polymeric material containing a second molecular weight greater than the first molecular weight to remain within the cavity formed by dissolving the first material.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert comprises an erodible material shaped to have an anterior surface and a posterior surface, each surface having a curvature corresponding to one or more surfaces of the soft contact lens, a circular region shaped to define an inner optical chamber, an outer region, and an extension extending between the inner and outer regions, the extension comprising a maximum dimensional span having a size less than a diameter of the circular region.

In another aspect, an erodible insert for use in the manufacture of soft contact lenses is provided. The insert comprises an erodible material shaped to have an anterior surface and a posterior surface, each surface having a curvature corresponding to one or more surfaces of the soft contact lens, the anterior and posterior surfaces being sufficiently smooth to impart optical qualities for correcting vision with the contact lens, a circular region shaped to define an inner optical chamber, an outer region, and an extension extending between the inner and outer regions, the extension comprising a maximum cross-sectional dimension of a size less than a diameter of the circular region, the outer region comprising a maximum dimensional span of a size greater than the maximum cross-sectional dimension of the extension.

In many embodiments, the cavity may be formed by an insert having an optically smooth surface. To allow for vision correction, the upper and lower portions of the lens body defining the optical chamber may include optically smooth surfaces.

In many embodiments, the cavity may be formed by an insert having an optically smooth surface. To allow for vision correction, the upper and lower portions of the lens body defining the optical chamber may include optically smooth surfaces. The surface may have an RMS value of about 50nm or less.

In many embodiments, the cavity may include particles contained within the cavity.

In many embodiments, the cavity can contain particles having a size larger than the channel size of the hydrogel polymer defining the cavity to contain the particles within the cavity.

In many embodiments, the cavity may contain one or more of soluble particles, partially soluble particles, or insoluble particles contained within the cavity. The particles may include a size greater than the channel size of the hydrogel polymer defining the cavity to contain the particles within the cavity.

In many embodiments, the cavity can include a polymer comprising acetate.

In many embodiments, the cavity may include a refractive index gradient. The refractive index gradient may include a greater refractive index near the boundary of the cavity and a smaller refractive index inside the cavity away from the boundary.

In many embodiments, the insert may include hydrogen bonding between at least a portion of the insert and the hydrogel contact lens material so as to provide a cavity having a refractive index gradient. The refractive index gradient may include a greater refractive index near the boundary of the cavity and a smaller refractive index inside the cavity away from the boundary.

In many embodiments, the cavity insert may include tapered edges to suppress refraction associated with abrupt changes in refractive index near the boundaries of the cavity formed in the hydrogel contact lens material.

In many embodiments, the cavity may contain solubilized polymer particles having insoluble pendant groups. The hydrogel may contain channels made of a hydrophilic material to allow water to pass through when hydrated, while the insoluble side groups retain the polymer particles within the chamber when hydrated.

In many embodiments, the hydrogel polymer surrounding the cavity can be configured to replace at least a portion of the liquid contained within the cavity with tear fluid when placed on the eye of a wearer.

In many embodiments, the hydrogel polymer surrounding the lumen can be configured to release liquid from within the lumen to the exterior of the soft contact lens to provide liquid to the eye.

In many embodiments, upon hydration, the refractive index of the material within the cavity may be less than the refractive index of the hydrogel material encapsulating the cavity. The cavity may be shaped to add negative power to the lens through the material contained therein.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side can include a posterior thickness. The anterior thickness may be less than the posterior thickness to facilitate flexing of the anterior surface of the lens and increase the optical power of the interior portion of the chamber when the contact lens includes a near vision correcting configuration with presbyopia accompanied by swelling.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side can include a posterior thickness. The anterior thickness may be less than the posterior thickness, and the anterior and posterior surfaces may flex as the optically interior portion of the chamber expands. The anterior surface may be flexed beyond the posterior surface by expansion to correct presbyopia.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side includes a posterior thickness. The anterior thickness may be at least about 50 um.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side includes a posterior thickness. The anterior thickness may not exceed about 100 um.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side can include a posterior thickness. The front thickness may be within a range defined between any two of the following values: about 10 microns, about 25 microns, about 50 microns, about 100 microns, about 150 microns, and 200 microns.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side can include a posterior thickness. The back thickness may be at least about 100 um.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body within the optically used portion of the cavity. The anterior side of the contact lens body can include an anterior thickness and the posterior side can include a posterior thickness. The back thickness may be no more than about 200 um.

In many embodiments, the material channel of the hydrogel contact lens body can be sized to allow disinfectant to flow from the chamber to the eye and inhibit bacteria from entering the chamber from outside the lens body.

In many embodiments, the cavity may comprise a different refractive index than the hydrogel material of the contact lens body encapsulating the cavity.

In many embodiments, the cavity may comprise a different refractive index than the hydrogel material of the contact lens body encapsulating the cavity. The refractive index of the cavity may differ from the refractive index of the material encapsulating the cavity by at least about 0.03.

In many embodiments, the cavity may comprise a different refractive index than the hydrogel material of the contact lens body encapsulating the cavity. The refractive index of the cavity may differ from the refractive index of the material encapsulating the cavity by at least about 0.05.

In many embodiments, the cavity may comprise a different refractive index than the hydrogel material of the contact lens body encapsulating the cavity. The refractive index of the cavity may differ from the refractive index of the material encapsulating the cavity by at least about 0.10.

In many embodiments, the cavity may comprise a refractive index similar to the hydrogel material of the contact lens body encapsulating the cavity. The refractive index of the cavity may be within about 0.03 of the refractive index of the material encapsulating the cavity.

In many embodiments, the cavity may comprise a refractive index similar to the hydrogel material of the contact lens body encapsulating the cavity. The refractive index of the cavity may be within about 0.05 of the refractive index of the material encapsulating the cavity.

In many embodiments, the cavity may include a negative power that refracts light in a distance-vision configuration. The anterior and posterior surfaces of the lens body may each be configured with a radius of curvature of the cavity to provide distance vision correction.

In many embodiments, the cavity may include an inner optical chamber for providing optical correction, and first and second outer chambers connected by one or more channels extending therebetween. The first outer chamber may be located below the inner chamber. The first outer chamber may include a quantity of fluid to provide intermediate vision correction to the inner optical chamber. The second outer chamber may include an amount of fluid to provide near vision correction when combined with fluid from the first outer chamber. The first outer chamber may be positioned below the second outer chamber to engage the first outer chamber with the eyelid to provide intermediate vision correction and to engage the eyelid with both the first outer chamber and the second outer chamber to provide near vision correction.

In many embodiments, the fluid contained within the lumen may comprise an osmolality in the range of about 200 (two hundred) to about 290mOsmol/L (two hundred ninety milliosmoles per liter).

In many embodiments, the fluid contained within the lumen may comprise an osmolality in the range of about 250 to about 290mOsmol/L (two hundred ninety milliosmoles per liter).

In many embodiments, the liquid contained within the lumen may include particles composed of a hydrophobic material to inhibit release of the particles through the hydrogel material encapsulating the lumen.

In many embodiments, the liquid contained within the cavity may include particles composed of a hydrophobic material comprising acetate to inhibit release of the particles through the hydrogel material encapsulating the cavity.

In many embodiments, the lens body may include polymer side chains extending into the cavity to provide a gradient index of refraction.

In many embodiments, the lens body can include acetate-containing polymer side chains extending into the cavity to provide a gradient index of refraction.

In many embodiments, the interface of the cavity and the contact lens body can include HEMA hydrophilically bonded to polyvinyl alcohol (PVA).

In many embodiments, the insert may include polyvinyl alcohol (PVA) and acetate (Ac).

In many embodiments, the insert may include a copolymer of polyvinyl alcohol (PVA) and polyvinyl acetate (PVAc).

In many embodiments, the insert may comprise a copolymer of polyvinyl alcohol (PVA) and polyvinyl acetate (PVAc) with vinyl acetate groups interspersed between the vinyl alcohol groups.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains comprising polyvinyl alcohol (PVA) and vinyl acetate (VAc) along each of the plurality of chains.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains comprising vinyl alcohol (PVA) and vinyl acetate (VAc) along each of the plurality of chains. Each of the plurality of chains can have from about 1000 to about 1500 pendant groups comprising a combination of an alcohol and an acetate.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains consisting of polyvinyl alcohol (PVA) and polyvinyl acetate (VAc) along each of the plurality of chains. Each of the plurality of chains may be configured to erode from the insert. The plurality of polymer chains can have an average molecular weight in the range of about 50kD to about 150 kD.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains consisting of polyvinyl alcohol (PVA) and polyvinyl acetate (VAc) along each of the plurality of chains. Each of the plurality of chains may be configured to be spaced apart from other chains and erode from the inlay. The plurality of polymer chains can have an average molecular weight in the range of about 50kD to about 110 kD.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains consisting of polyvinyl alcohol (PVA) and polyvinyl acetate (VAc) along each of the plurality of chains. Each of the plurality of chains may be configured to be spaced apart from other chains and erode from the inlay. The plurality of polymer chains can have an average molecular weight in the range of about 100kD to about 110 kD.

In many embodiments, the insert may comprise a solid material composed of a plurality of polymer chains consisting of polyvinyl alcohol (PVA) and polyvinyl acetate (PVAc) along each of the plurality of chains. Each polymer chain may comprise from about 0.05% to about 10% PVAc and from about 90% to about 99.5% PVA. Vinyl acetate groups may be interspersed between vinyl alcohol groups.

In many embodiments, the insert may comprise a solid material composed of polyvinyl alcohol (PVA) polymer and polyvinyl acetate (PVAc). The PVAc can comprise an amount of about 1% to about 20% by weight of the material. PVA may comprise an amount of about 99% to about 80% by weight.

In many embodiments, the lumen may contain a therapeutic agent selected from the group consisting of: anti-infectives, including but not limited to antibiotics, antivirals, and antifungals; anti-allergenic agents and mast cell stabilizers; steroidal and non-steroidal anti-inflammatory agents; cyclooxygenase inhibitors, including but not limited to Cox I and Cox II inhibitors; a combination of an anti-infective agent and an anti-inflammatory agent; a decongestant; anti-glaucoma agents including, but not limited to, adrenergic agents, beta adrenergic blockers, alpha adrenergic agonists, parasympathomimetic agents, cholinesterase inhibitors, carbonic anhydrase inhibitors, and prostaglandins; combinations of anti-glaucoma agents; an antioxidant; a nutritional supplement; drugs for the treatment of cystoid macular edema, including but not limited to non-steroidal anti-inflammatory agents; drugs for the treatment of ARMD, including but not limited to angiogenesis inhibitors and nutritional supplements; medicaments for the treatment of herpes infections and CMV ocular infections; drugs for the treatment of proliferative vitreoretinopathy including, but not limited to, antimetabolites and fibrinolytic agents; wound modulators, including but not limited to growth factors; an antimetabolite; neuroprotective drugs including, but not limited to, eliprodil; and angiogenesis inhibiting steroids for use in the treatment of posterior segment diseases or conditions, including but not limited to ARMD, CNV, retinopathy, retinitis, uveitis, macular edema, and glaucoma.

In many embodiments, the insert may comprise a material capable of bending to a radius of curvature in a range of about 5mm to about 1 meter. The material may optionally comprise an elastic material.

In many embodiments, the cavity may include one or more channels to facilitate removal of residual insert material. The one or more channels may be formed by piercing the lens body with a syringe, needle or laser. Alternatively or in combination, the one or more channels may be formed by chemical attack of a predetermined portion of the lens body. Alternatively or in combination, one or more channels may be formed by erosion of the insert. The insert may comprise one or more protrusions correspondingly shaped as one or more channels. Alternatively or in combination, one or more channels may be formed outside the optical zone to reduce the visual aberrations of the lens. Alternatively or in combination, one or more channels may be formed towards an outer edge of the lens, a rear surface of the lens, or a front surface of the lens. Alternatively or in combination, the one or more channels may be in one or more of the following situations after insert erosion and cavity formation: filled, plugged, sealed with a polymer of the polymer making up the contact lens, or welded.

In many embodiments, the insert may include one or more protrusions shaped to define one or more channels in the lens body from the cavity to one or more outer sides of the lens after formation of the lens around the insert and erosion of the insert.

In many embodiments, the cavity may contain residual insert material. The inner surface of the cavity may include a residual surface structure comprising a residual insert material. The residual surface structure may be optically smooth. The residual surface structure may optionally include non-visually perceptible artifacts.

In many embodiments, the insert may have a thickness within a range defined between any two of the following values: about 0.5 microns, about 15 microns, about 50 microns, about 75 microns, and about 100 microns.

In many embodiments, the insert may have a thickness greater than about 100 microns.

In many embodiments, the insert may comprise an insert material selected from the group consisting of: insert materials that are soluble, erodible, degradable and liquefiable by aqueous solution, alcohol or solvent.

In many embodiments, the insert may comprise an insert material selected from the group consisting of a moldable insert material, an extrudable insert material, and a photocurable insert material.

In many embodiments, the insert material may comprise a material selected from a sugar or sugar alcohol. The insert material may include a sugar. The sugar may be selected from: monosaccharides, disaccharides, and polysaccharides. Alternatively or in combination, the sugar may be selected from: fructose, galactose, glucose, glyceraldehyde, lactose, maltose, ribose, sucrose, cellulose, and methyl cellulose. Alternatively or in combination, the insert material may comprise a sugar alcohol. The sugar alcohol may be selected from: arabitol, D-sorbitol, erythritol, fucitol, galactitol, glycerol, iditol, inositol, isomaltitol, lactitol, maltotetraitol, maltitol, maltotriose, mannitol, inositol, polydextrose, ribitol, sorbitol, threitol, and xylitol.

In many embodiments, the intercalate material may comprise a material selected from the group consisting of dimethyl sulfoxide (DMSO), N-vinyl pyrrolidone (NVP), polyethylene glycol (PEG), sodium polymethacrylate, Methocel^TME6, polyvinyl alcohol (PVA), polyvinyl acetate (PVAc), and copolymers of PVA and PVAc.

In many embodiments, the insert material may comprise a material selected from the group consisting of sodium chloride, sodium carbonate, and potassium chloride.

In many embodiments, the lens may be formed by one or more of casting, extrusion, molding, or lamination.

In many embodiments, the lens may comprise a material selected from the group consisting of: acofilcon A, acofilcon B, alfafilcon A, altafilcon A, atlafilcon A, balafilcon A, bufilcon A, comfilcon A, crofilcon, deltafilcon A, dimefilcon A, droxifilcon A, efroffilcon A, enfilcon, epsilon filcon A, etafilcon A, focfilcon A, galyfilcon A, glifilcon A, glilcon B, heifilcon C, hilafilcon A, hilafilcon B, hiofilcon A, hiofilcon B, hiofilcon A, hydroxyfilcon B, oxifilcon D, isofilcon, lidilcon A, lidifilcon B, lidocon A, dolafilcon B, lopilcon A, filcon B, flavofilcon A, filcon B, filcon A, filcon B, flavofilcon A, filcon B, filcon A, filcon B, filcon A, fillcocon A, filcon B, filcon A, filcon B, filcon A, filcon B, filcon A, filcon B, filcon A, filcon B, filcon A.

In many embodiments, the cavity may be defined by an inner wall of the lens body.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body located within the optically used portion of the cavity. When the contact lens includes a presbyopic corrective near vision configuration with inflation, the anterior side of the contact lens body may flex, thereby providing increased optical power of the intracavitary portion. The flexure may provide a uniform change in optical power of the interior portion of the cavity.

In many embodiments, the inner cavity providing the optical correction may be enclosed on the anterior and posterior sides with the contact lens body located within the optically used portion of the cavity. When the contact lens includes a presbyopic corrective near vision configuration with inflation, the anterior side of the contact lens body may flex and may provide increased optical power of the intracavitary portion. The flexure may provide a uniform change in optical power of the interior portion of the cavity.

In many embodiments, the contact lens may include a multifocal profile having different regions of different optical powers. The contact lens may optionally include a multifocal profile in a near vision configuration.

In many embodiments, the contact lens may include a multifocal profile having a continuously varying power region. The contact lens may optionally include a multifocal profile in a near vision configuration.

In many embodiments, the cavity may include a cross-linked insert material. The cavity may include an insert material crosslinked to the lens body and extending from the lens body into the cavity. Alternatively or in combination, the cavity may comprise an insert material that is cross-linked to the lens body and extends from a surface of the lens body into the cavity to another surface of the lens body.

In many embodiments, the insert may contain UV blockers or absorbers to prevent or alter the extent or location of cross-linking of the intraluminal insert. Alternatively or in combination, the insert may comprise an insert material that does not crosslink upon exposure to UV light.

In many embodiments, the cavity may contain a therapeutic agent. The therapeutic agent may have a half-life in the range of about 1 day to about 7 days. The hydrogel polymer surrounding the cavity can be configured to release a liquid containing a therapeutic agent from within the cavity to the exterior of the soft contact lens to provide the therapeutic agent to the eye. Alternatively or in combination, the insert may comprise a therapeutic agent that remains in the cavity after dissolution of the insert. Alternatively or in combination, the lumen may be equilibrated with an external solution comprising a therapeutic agent such that the lumen comprises the therapeutic agent.

In many embodiments, the amount of intraluminal therapeutic agent can be controlled by concentration, size of the therapeutic agent, molecular weight of the therapeutic agent, temperature, aperture of the lens body, thickness of the posterior side of the lens, or thickness of the anterior side of the lens.

In many embodiments, the back side of the lens may comprise a thickness in a range defined between any two of the following values: about 10 microns, about 25 microns, about 50 microns and about 100 microns and about 200 microns.

In many embodiments, the therapeutic agent can comprise a molecular weight in the range of about 18 daltons to about 10 kilodaltons.

In many embodiments, the front side of the lens may include a thickness within a range defined between any two of the following values: about 10 microns, about 25 microns, about 50 microns, about 100 microns, about 150 microns, and 200 microns.

In many embodiments, the cavity can contain a therapeutic amount of a therapeutic agent. The therapeutic amount may change the refractive index of the cavity by about 0.01 to about 0.02 such that the presence of the therapeutic agent in the cavity does not significantly change vision.

In many embodiments, the cavity may contain a therapeutic agent. The chamber may be located near the posterior lens surface, near the anterior lens surface, or near the center of the lens to control the release of the therapeutic agent to the eye. Alternatively or in combination, the cavity may be located outside the optical zone.

In many embodiments, a soft contact lens can include a first cavity located within an optical zone of the lens and a second cavity located outside the optical zone. The first cavity may provide optical correction to the lens when flexed. The second chamber can contain a therapeutic agent and provide the therapeutic agent to the eye through the lens body.

In another aspect, a method is provided. The method includes providing any of the contact lens embodiments described herein. Alternatively or in combination, the method includes providing any of the erodable insert embodiments described herein.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

fig. 1A shows a cross-sectional view of a contact lens including a lumen, in accordance with an embodiment;

FIG. 1B shows an enlarged cross-section of a contact lens as in FIG. 1A, according to an embodiment;

fig. 2 shows a cross-sectional view of a contact lens in sterile packaging having a cavity in equilibrium with the fluid in which the lens is packaged, according to an embodiment.

FIG. 3A illustrates a cross-sectional view of a curved insert including a soluble polymer, according to an embodiment;

FIG. 3B shows a top view of the curved insert as in FIG. 3A including a soluble polymer;

FIG. 4 illustrates a contact lens cavity after dissolution of an insert according to an embodiment;

FIG. 5 illustrates a contour plot of a lens resulting from expanding an optical chamber of a chamber due to simulated motion of a lower eyelid on a contact lens, in accordance with an embodiment;

FIG. 6 illustrates a stabilized contact lens according to an embodiment;

FIG. 7 illustrates a contact lens including a sensor, wherein at least a portion of the sensor is located within a cavity, according to an embodiment;

FIG. 8 illustrates a method of manufacturing a lens including a cavity formed by dissolving an insert, in accordance with an embodiment;

fig. 9A illustrates a cross-sectional view of a contact lens including a lumen containing residual insert material, in accordance with an embodiment;

FIG. 9B illustrates an erodible insert material comprising a copolymer of polyvinyl alcohol and polyvinyl acetate, in accordance with an embodiment;

fig. 10 shows a contact lens with a single peripheral reservoir, in accordance with an embodiment;

fig. 11 shows a contact lens with progressive peripheral reservoirs according to an embodiment;

fig. 12 shows a contact lens with two peripheral reservoirs according to an embodiment;

fig. 13A shows a cross-sectional view of a contact lens including a lumen and a hole, in accordance with an embodiment;

FIG. 13B illustrates a cross-sectional view of an insert including a protrusion, according to an embodiment;

fig. 13C shows a cross-sectional view of a contact lens including a lumen and a fill hole, in accordance with an embodiment;

figure 14 shows a cross-sectional view of a contact lens including an inner cavity and including a multifocal lens, in accordance with embodiments;

FIG. 15 shows a cross-sectional view of a contact lens including a lumen having a cross-linked material, in accordance with an embodiment;

fig. 16 illustrates a cross-sectional view of a contact lens including a lumen containing a drug therein, in accordance with an embodiment;

FIG. 17 shows a cross-sectional view of a contact lens including an inner lumen proximate a posterior side of the lens and containing a drug therein, in accordance with an embodiment;

FIG. 18 shows a cross-sectional view of a contact lens including a lumen proximate the anterior side of the lens and containing a drug therein, in accordance with an embodiment;

fig. 19 shows a cross-sectional view of a contact lens including a lumen external to the optical zone and containing a drug therein, in accordance with an embodiment;

FIG. 20 shows simulation results of lens power as a function of a back radius of curvature of a cavity, in accordance with an embodiment;

FIG. 21 shows simulation results of lens power as a function of cavity position within a lens according to an embodiment;

FIGS. 22A-22B illustrate a casting cup for casting an adjustable contact lens according to embodiments;

fig. 23A shows an adjustable contact lens after 2 hours of hydration in 0.9% saline and 1.5 hours of sonication, in accordance with an embodiment;

fig. 23B shows an adjustable contact lens after overnight hydration, in accordance with an embodiment;

FIG. 24 illustrates an adjustable soft contact lens with an embedded cavity under bright field microscopy according to an embodiment;

FIG. 25 shows an adjustable soft contact lens including a cavity on the eye, in accordance with an embodiment;

FIG. 26 shows an adjustable soft contact lens including a dye chamber on the eye, in accordance with an embodiment;

FIG. 27 shows a lens power measurement test for an adjustable soft contact lens according to an embodiment;

fig. 28A shows the adjustable soft contact lens of fig. 26 on-eye, in accordance with an embodiment;

FIG. 28B shows a cross section of Optical Coherence Tomography (OCT) of the contact lens of FIG. 28A, in accordance with embodiments;

FIG. 29 shows an adjustable soft contact lens according to an embodiment comprising a cavity with a central ridge on the eye;

fig. 30A shows the adjustable soft contact lens of fig. 29 on-eye, in accordance with an embodiment;

FIG. 30B shows an OCT cross-section of the contact lens of FIG. 30A, in accordance with an embodiment;

fig. 31 shows a method of manufacturing a contact lens comprising a cavity according to an embodiment;

fig. 32 shows a lens comprising a low molecular weight dye prior to incubation in an extraction solution, in accordance with an embodiment;

FIG. 33 shows the lens of FIG. 32 after incubation in extraction solution for 24 hours, according to an embodiment;

fig. 34A is a lens including a low molecular weight dye prior to incubation in an extraction solution, according to an embodiment;

FIG. 34B shows the lens of FIG. 34A after 5 hours of incubation in the extraction solution, in accordance with an embodiment;

FIG. 34C shows the lens of FIG. 34A after 5 hours of incubation in the extraction solution, in accordance with an embodiment;

FIG. 34D is a lens including a low molecular weight dye prior to incubation in an extraction solution, according to an embodiment;

FIG. 34E shows the lens of FIG. 34D after 5 hours of incubation in the extraction solution, in accordance with an embodiment;

FIG. 34F shows the lens of FIG. 34D after 5 hours of incubation in the extraction solution, in accordance with an embodiment;

fig. 35A shows a sucrose film produced using an cast-free process according to an embodiment;

fig. 35B shows a sucrose film produced using an cast-free process, in accordance with an embodiment;

fig. 35C shows a self-supporting sucrose film produced using an cast-free process, in accordance with embodiments;

fig. 36A illustrates the flexibility of a sucrose insert membrane, in accordance with an embodiment;

FIG. 36B illustrates the flexibility of a glucose insert membrane according to an embodiment;

fig. 36C shows the flexibility of the isomalt insert film according to an embodiment;

figure 36D shows the results of cavity formation after sucrose insert diffusion according to an embodiment;

FIG. 36E shows the result of cavity formation after diffusion of the glucose insert, according to an embodiment;

fig. 36F shows the result of cavity formation after isomalt insert diffusion according to an embodiment;

fig. 37A shows an insert made of sodium chloride, in accordance with an embodiment;

FIG. 37B shows the result of cavity formation after sodium chloride insert diffusion according to an embodiment;

FIG. 37C shows the result of cavity formation after sodium chloride insert diffusion according to an embodiment; and

fig. 37D shows the results of cavity formation after sodium chloride insert diffusion according to an embodiment.

Detailed Description

The cavity lenses disclosed herein are well suited for combination with many prior art lenses, such as contact lenses. For example, the cavity lens may be combined with an adjustable soft contact lens or an adjustable intraocular lens.

Soft contact lenses, which include a fluid-filled chamber, function as dynamically adjustable contact lenses, providing the presbyopic subject with the required refractive correction at all distances from far to near. The cavity includes an optical chamber aligned with the optical center of the lens itself and a peripheral chamber positioned vertically below the optical chamber and connected to the optical chamber by a channel. When mounted on the eye, the optical chamber of the cavity is positioned above the center of the pupil, while the peripheral chamber is positioned to interact with the lower eyelid when looking down. Pressure from the lower eyelid forces fluid from the peripheral chamber into the optical chamber, causing the cavity to expand and push against the anterior surface of the contact lens, causing its curvature to become steep. Thus, as long as the peripheral chambers of the chamber remain compressed by the lower eyelid, the lens center continues to experience a positive power increase to correct near vision. The design and manufacturing process of such soft contact lenses is disclosed herein.

The adjustable soft contact lenses described in the following patent applications are well suited for combination with the cavity contact adjustable contact lenses described herein: WO/2015/095891 entitled "FLUID MODULE FOR ACCOMATING SOFT CONTACT LENS" and WO/2014/117173 entitled "ACCOMATING SOFT CONTACT LENS," the entire disclosures of which are incorporated herein by reference.

The present inventors have designed and manufactured a spherical soft contact lens that contains an insert cavity that serves as an adjustable contact lens. The cavity may have a well-defined circular optical chamber and a lower peripheral chamber connected to the optical chamber by a channel. The cavity is formed by placing an insert made of a water-soluble polymer of appropriate shape and thickness within the mold cavity used to form the contact lens. The lens is hydrated after curing. The insert dissolves in the hydration medium, which is typically saline, thereby filling the cavity with saline. Preferably, a low expansion polymer is used to form the contact lens such that the size of the cavity does not change when the lens is hydrated. The adjustable contact lens may be configured in a number of ways, including a single focus aspheric design — a single focus stabilized lens for enhanced rotational stability. The inventors have fabricated lenses as described herein and have conducted experiments.

As used herein, "PVA" refers to polyvinyl alcohol.

As used herein, "PVAc" refers to polyvinyl acetate.

Figure 1A shows a cross-sectional view of a hydrogel contact lens 100 including a lumen 110. Although a contact lens is shown, the body having the cavity can be many items other than a contact lens. The cavity 110 may be formed by dissolving a solid material (e.g., an insert), thereby giving the cavity 110a shape profile and structure that corresponds to the shape profile and structure of the dissolved insert. The lens 100 includes a lens material 120 having sufficient rigidity to maintain the shape of the dissolvable insert after hydration and insert dissolution. The inner surface of the cavity 110 may include an optically smooth surface through which light may pass to correct vision. The cavity 110 may include one or more internal structures formed by dissolving the erodable material. One embodiment of a dissolvable insert is described in more detail in fig. 3. The lens cavity 110 can be shaped in a number of ways, as defined by the shape of the dissolvable insert, thereby making it easy to manufacture the cavity 110 within the contact lens 100.

Fig. 1B shows an enlarged cross-section of the contact lens 100 depicting the cavity 110 with a portion 130 of the contact lens body 120. The cavity 110 is filled with a volume of cavity fluid 112 comprising, for example, about 1 μ L to 5 μ L of residual dissolved insert material or fluid for hydrating the lens 100. The residual insert material 112 may have a molecular weight within one or more of a number of ranges, such that the residual insert material 112 is capable of diffusing through the polymer of the contact lens body 120. The molecular weight range can be about 3 kDalton (kD) to about 10kD, and can be about 3kD to about 7 kD. The upper contact lens surface 132 of the substrate forming the cavity 110 includes an exposed polymer 134 in contact with the cavity fluid 112. The lower contact lens surface 136 comprises a posterior lens surface that may contact the eye.

Fig. 2 shows a cross-sectional view of a contact lens 100 in a sterile package 200, wherein the cavity 110 is equilibrated 202 with a fluid 204 in which the lens is packaged. Contact lens 100 may be immersed in sterile fluid 204 within a sterile package. The cavity 110 is filled with a liquid 112 and is permeable to an aqueous fluid 204 in which the lens is packaged, such that the cavity 110 is in equilibrium 202 with the fluid 204 outside the lens body 120. At least a portion of the fluid 204 may diffuse into the cavity 110. When placed on the eye, the permeability of the contact lens 100 allows the lens 100 to wet the eye with the chamber fluid 112.

Fig. 3A shows a cross-sectional view of an insert 140 made of a soluble polymer. The insert 140 includes a three-dimensional shape profile having a substantially uniform thickness that, upon dissolution, corresponds to the shape of the cavity 110. The insert 140 may comprise a material having a molecular weight of at least 3 kdaltons in order to add sufficient rigidity to the material to maintain a given shape at processing temperatures that may be in the range of 10 ℃ to 45 ℃. The insert 140 preferably comprises a low expansion polymer so that hydration of the lens does not change the size of the cavity 110. The upper surface 142 and the lower surface 144 of the insert 140 may also have a curvature corresponding to the curvature of the mold used to define the curvature of the base of the lens 100. Fig. 22A-22B illustrate one example of such a mold.

The contact lens material may include a small amount of expansion when hydrated. The lens material may be cured in the mold with the insert and then hydrated as described herein. Low swelling hydrogel materials are described in U.S. Pat. No. 62/254,048 entitled "SOFTTACT LENS MATERIAL WITH LOW VOLUMETRIC EXPANSION UPON HYDRATION," filed 11/2015, the entire disclosure of which is incorporated herein by reference.

Fig. 3B shows a top view of the insert 140 as in fig. 3A. The insert 140 may include a shape having a portion 146 corresponding to an inner optical chamber of the lens 100, a portion 148 corresponding to a lower chamber of the lens 100, and a portion 147 corresponding to a channel extending between the chambers. The diameter 149 of the portion 147 corresponding to the channel may be in the range of about 0.2mm to 2 mm. When the insert 140 is dissolved within the lens body 120, the resulting cavity 110 can retain the shape profile of the insert 140.

The insert 140 may be sized and shaped in any number of ways suitable for application of a body comprising a polymer. For example, the insert may include a three-dimensional shape profile. The insert 140 may be formed in a number of ways, such as using three-dimensional printing. The three-dimensional shape profile may include an outer boundary that defines an outer boundary of the cavity 110. The shape profile may include one or more curved surfaces that correspond to one or more surfaces of the contact lens (e.g., to the curvature of the lower base of the contact lens). The insert may be manufactured in a number of ways, for example using three-dimensional printing of the insert material.

Fig. 4 shows contact lens 100 and cavity 110 after insert 140 has dissolved. Upon hydration of the contact lens 100, the insert 140, which may have a shape profile as shown in fig. 3B, dissolves to form a cavity 110 corresponding to the shape of the dissolved insert 140. As the insert 140 dissolves, diffusion of the dissolved insert material out of the cavity 110 may inhibit osmotic pressure and expansion of the cavity 110, such that the structural integrity of the lens body 120 and the cavity 110 may be maintained. The insert material can diffuse through the polymeric material of the body at a sufficient rate to inhibit the build-up of osmotic pressure that might otherwise compromise the structural integrity of the soft lens material and the shape of the cavity formed.

The chamber 110 may be shaped to correct vision when in equilibrium with the tear fluid of the eye. The cavity 110 may include an inner optical chamber 114 corresponding in shape and structure to a portion 146 of the insert 140, a lower chamber 116 corresponding to a portion 148 of the insert 140, and a channel 118 extending therebetween corresponding to a portion 147 of the insert 140. The contact lens 100 can also include one or more articulating portions coupled to the inner optical chamber 114 and the lower chamber 116. The lower chamber 116 includes a liquid reservoir in fluid communication with the inner optical chamber 114 via a channel 118.

The inner optical chamber 114 and the lower chamber 116 may be configured in a number of ways.

The chamber 110 can provide hydration to the eye as water, saline, or other fluids are released through the lens body 120 to moisturize the eye.

The lens body 120 may include a polymer that constitutes a channel sized to allow water to diffuse between the cavity 110 and the outside of the lens body and also sized to prevent bacteria from entering the cavity 110 from the outside of the lens body.

The chamber 110 may include a drug including, but not limited to, timolol that may be released through the lens body 120 to treat the eye.

Figure 5 shows a contour plot of the lens resulting from the expansion of the optical chamber of the chamber by the simulated action of the lower eyelid on the contact lens. When the lower eyelid engages the lower chamber 116, which includes a reservoir of liquid, fluid is transferred to the inner optical chamber 114 through the channel 118 to increase the curvature of the inner optical chamber 114 and provide optical power for near vision. Lens 100 may include a polymer with a sufficient amount of cross-linking to retain fluid in inner optical portion 114 when lower portion 116 engages the eyelid to generate additional positive power to correct near vision of the eye when looking down at an object. While the polymer may allow for equilibration, the amount of fluid released from the lens during accommodation is low enough to allow for optical correction.

The generated add power may range from about 0.5D to 6.0D, wherein the down gaze may be in the range of 10 ° to 40 °, and the object being viewed may be at a distance in the range of about 15cm to 200 cm. The central region of the optical zone above the optical chamber exhibits an increase in height of 75um relative to the remainder of the lens sufficient to provide near vision to correct presbyopia with a power in the range of about 0.5D to 6.0D (e.g., in the range of about 0.5D to about 3D).

The fluid 112 contacting the lens body 120 may comprise an index of refraction in the range of about 1.31 to about 1.37 (and about 1.33 to about 1.36). The contact lens body 120 may include an index of refraction in the range of about 1.37 to about 1.48 (and about 1.37 to about 1.45). For example, the refractive index of the contact lens material may be greater than the refractive index of the fluid within the cavity.

The cavity lens embodiments disclosed herein are well suited for combination with many prior art lenses, including rotationally stabilized contact lenses.

Fig. 6 illustrates a stabilized contact lens suitable for combination with a cavity lens and an insert as described herein. Stabilized lenses are described in the following patent applications: U.S. serial No. 62/254,080 entitled "rotalinally static personnel LENS" filed 11/2015 on day 11; and U.S. serial No. 62/255,242 entitled "rotalinally static CONTACT LENS," filed on day 11, 13 of 2015, the entire disclosure of which is incorporated herein by reference.

The lens 100 includes a structural arrangement for stabilizing the lens. The upper stable zone 210 is generally located above the optical zone 170. The upper stable region 210 includes a crescent shape. Lower stable region 220 is positioned below the upper stable region and extends substantially around optical zone 170. The lower stabilization zone 220 comprises a generally annular shape and extends around at least about half of the optical zone 170. The lower stabilization zone 220 includes an upper boundary that is shaped to mate with and correspond to the lower boundary of the upper stabilization zone. The lower stabilization zone 220 includes a thickness greater than the upper stabilization zone in order to stabilize the lens on the eye.

Lens 100 includes a pressure sensitive zone 230 coupled to optical zone 170. The pressure sensitive region 230 includes a lens shape having a thickness less than the lower stable region 220 so as to couple pressure from the eyelid to the pressure sensitive structure within the pressure sensitive region. The pressure sensitive zone 230 is generally located between the lower boundary of the lens and the optical zone 170. The lower stabilizing zone 220 includes a lower boundary that is shaped to mate with and correspond to the upper boundary of the pressure sensitive zone 230. Lens 100 includes a midline 240 extending through center 250 and corresponding to the 90 degree axis of lens 100. The stabilization structures of the lens may be symmetrically disposed about the midline 240.

Optical zone 170 may include a pressure sensor or lower chamber fluid module coupled to pressure sensing zone 230, as described in application PCT/US2014/071988, the entire disclosure of which is incorporated herein by reference.

Optical zone 170 may include an optical fluid chamber configured to increase in curvature in response to eyelid pressure on pressure sensing zone 230. Pressure sensing region 230 includes a fluid reservoir chamber coupled to an optical chamber with a channel extending therebetween to deliver fluid to the optical chamber in response to eyelid pressure.

In alternative embodiments, optical zone 170 may include liquid crystal material between electrodes, with pressure sensing region 230 including a pressure sensor electrically coupled to the electrodes to increase the optical power of the liquid crystal material in response to eyelid pressure sensed by the pressure sensor.

The optical zone 170 includes a maximum dimensional span, such as a diameter 180 of the optical zone. Lens 100 includes a maximum dimensional span, such as diameter 190.

Upper and

lower stabilization zones

210 and 220 may each include a surface area greater than the pressure sensing zone to stabilize the lens.

Fig. 7 shows a contact lens 100 that includes a sensor 150, at least a portion of which is located within the cavity 110. The cavity 110 can be formed on at least a portion of the sensor 150 embedded within the contact lens 100 in order to improve coupling of the sensor 150 to the external environment of the lens, such as tear fluid in contact with the contact lens on the active sensor region 152. Movement of the lower eyelid 160 may provide fluid to the outer surface of the contact lens near the sensor. The active sensor region 152 can be exposed to the fluid within the lens cavity and can therefore better measure tear fluid since the active sensor region 152 does not directly contact the material of the lens 100. The contact lens may comprise a stabilized lens as described herein.

The sensor 150 may include one or more of a pressure sensor, a glucose sensor, a biomarker sensor, an electrical sensor, and a sensor having ion-specific microelectrodes. For example, sensor 150 may include no greater than about 1.0mm³The volume of (a).

FIG. 8 illustrates a method of manufacturing a lens including a cavity formed by dissolving an insert, according to an embodiment. A base layer of lens material may be created. A small amount of about 10uL of lens prepolymer may be placed in the lower mold cavity cup (step 1) and partially cured using UV light or other suitable curing method defined by the prepolymer in use (step 2). Subsequently, an insert having a three-dimensional structure, such as insert 140 described herein, may be formed (step 3) and placed over the partially cured resin layer in the lower mold cavity cup (step 4). Additional prepolymer may then be delivered to the mold, possibly including the insert and partially cured resin, in an amount sufficient to complete lens formation (step 5). The lens may then be fully polymerized by curing under UV light, e.g. at a wavelength of about 390nm (step 6). The lens may then be removed from the mold (step 7), optionally placing the lens and mold in saline and sonicating to facilitate demolding (step 8), and hydrating for about 2-6 hours (step 9). After initial hydration, the lenses may be washed in dilute NaOH (e.g., 0.01M) (step 10) and further hydrated in saline (step 11) for about 6-24 hours. During the hydration of step 11, the brine may be replenished at least once (step 12). After the lens is hydrated, the insert is dissolved to form a cavity having a desired shape within the lens body, and the dissolved insert material can diffuse out of the lens body (step 13).

The method of fig. 8 illustrates a method of manufacturing a cavity in a body of material according to an example. One of ordinary skill in the art will recognize many variations. These steps may be performed in any order. Steps may be added or removed. The materials used may be varied so that the steps may be varied. For example, the prepolymer for the lens body may be crosslinked by a method other than photopolymerization, such as crosslinking using a catalyst, and thus the curing step may be changed to include such a method.

Turning again to FIG. 5, the inner optical chamber 114 provides an increased height contour to the upper surface of the lens to provide optical power with fluid from the lower chamber 116. The upper (anterior) surface of the lens 100 has an approximately spherical contour on the optical portion of the lens corresponding to the inner optical chamber 114. As shown, the surface height increases from about 0.006mm at the outer portion of the optical zone to about 0.075mm at the center of the optical zone. For example, the transition zone around the optical zone can include a height in the range of about 0.000mm to about 0.006 mm. The lower chamber 116 may also include an increased surface height profile relative to other locations of the lens 100. For example, the lower chamber 116 may include a height in the range of about 0.006mm to about 0.040mm compared to the adjacent position of the lens 100.

While the hydrogel of the contact lens body may comprise one or more of a number of hydrogel materials, in many embodiments, the hydrogel comprises hydroxyethyl methacrylate (HEMA). Hydrogels comprising HEMA can comprise channels or pores sized to allow water to diffuse into and out of the cavity from the exterior of the contact lens body as described herein. The channel of the hydrogel contact lens body can be sized to allow disinfectant to flow from the chamber to the eye and inhibit bacteria from entering the chamber from outside the lens body. The amount and density of cross-linking of the HEMA of the lens body can be configured to provide a channel of suitable size to allow water to diffuse into and out of the lens chamber and contain a portion of the solubilized material from the insert within the chamber.

The insert for forming the cavity may comprise one or more of a number of solid materials as described herein. In many embodiments, the insert material comprises polyvinyl alcohol (PVA), and the polymer chain of the PVA may comprise vinyl acetate (VAc) groups interspersed between the vinyl alcohol groups. As shown in fig. 9B, a copolymer of PVA and PVAc 260 can be produced by partially hydrolyzing polyvinyl acetate (PVAc) to PVA so as to have a mixture of pendant groups along the polymer chain 262 comprising acetate groups 266 and alcohol groups 264. The insert material may comprise a plurality of such copolymer chains configured to separate from one another when exposed to water to erode the insert. The solid insert material may be comprised of PVA and PVAc such that the PVAc is in the range of about 1% to about 20% by weight of the solid insert material and the PVA is in the range of about 99% to about 80% by weight of the solid insert material. Each of the plurality of polymer chains of the intercalate material may comprise a plurality of vinylic groups, having a plurality of pendant groups in the range of about 1000 to about 1500 pendant groups. For example, each of the plurality of polymer chains of the intercalate material may have about 1000 pendant groups, wherein about 10% of the pendant groups comprise PVAc and about 90% of the pendant groups comprise PVA. Each of the plurality of PCA/Ac polymer chains of the insert material may comprise about 0.05% to about 10% PVAc and about 90% to about 99.5% PVA. The pendant PVAc groups of each of the polymer chains of the intercalate material may be randomly interspersed among the pendant PVA groups. For example, each of the plurality of PVA/Ac chains of the insert material may have a molecular weight in a range of about 50 kilodaltons (kD) to about 150 kD. For example, each of the plurality of PVA/Ac chains of the insert material may have a molecular weight in the range of about 50kD to about 100 kD. For example, each of the plurality of PVA/Ac chains of the insert material may have a molecular weight in the range of about 100kD to about 110 kD. For example, the PVA/Ac chains may constitute at least about 50% of the erodible insert material, and the amount of PVA/Ac chains within the material may be in the range of about 60% to 99%.

The erodible insert material may be configured in a number of ways to provide beneficial properties to the material contained within the cavity. The erodible insert material may include a first polymer chain configured to dissolve and travel through the contact lens body and a second polymer chain configured to erode from the material and remain within the cavity. The amount of acetate side groups disposed along the PVA chain may be related to the solubility of the polymer chain. For example, the insert material may include a first PVA polymer chain having less than about 10% vinyl acetate along the PVA chain, and a second polymer chain having more than about 10% acetate along the PVA chain. PVA chains having less than about 10% acetate may travel through the channel of the contact lens body, while PVA chains having more than about 10% acetate may be prevented from traveling through the contact lens body and thus remain within the cavity.

As shown in fig. 9A, the cavity fluid 112 may contain residual dissolved insert material 113 as described herein. The residual inlay material 113 may, for example, comprise polymer particles or nanoparticles. The residual dissolved insert material 113 may provide the cavity 110 with a refractive index gradient near the boundaries of the cavity 110 to suppress abrupt changes in refractive index and optical artifacts perceptible to the wearer. The refractive index gradient of the cavity 110 may include a larger refractive index near the boundary of the cavity 110 and a smaller refractive index away from the lens body 120. The refractive index gradient may be formed by adsorbing the residual inlay material 113 onto the exposed lens body material 120 defining the cavity 110 or by a binding interaction between, for example, the lens body material 120 and the residual inlay material 113. The residual inlay material 113 may be more densely filled at the boundaries of the cavity 110 than near the interior of the cavity 110 in order to generate a refractive index gradient.

The refractive index gradient of the cavity may be formed by creating one or more bonds (e.g., cross-linking or hydrogen bonding) between the insert material and the hydrogel lens material. For example, the binding may occur as a result of the addition of a cross-linking agent to the insert. Alternatively or in combination, the intercalate material may be configured such that it comprises polymer chains having both hydrophilic and hydrophobic side groups thereon. The ratio of hydrophilic groups to hydrophobic groups may determine the solubility of each polymer chain, such that increasing the amount of hydrophobic side groups decreases the ability of the polymer chain to dissolve. The polymer chains with the added hydrophobic groups, such as acetate, may be folded upon themselves to cover at least a portion of the acetate groups for partial dissolution within the cavity. Incompletely dissolved polymer chains may form partially solubilized polymer particles that remain in the chamber in the liquid contained within the cavity. The polymer particles may be suspended in the cavity fluid. The particles may form a gel or gel-like network or substance within the cavity. These partially solubilized polymer particles may contain an increased amount of acetate groups as compared to more soluble polymer particles that readily dissolve and travel through the hydrogel contact lens body. The sparingly soluble polymers may contain insoluble or hydrophobic side group molecules (e.g. acetates) that inhibit diffusion of the sparingly soluble polymer particles through the hydrophilic lens material to provide a portion of the dissolved polymer particles within the chamber. The partially dissolved polymer particles can be adsorbed onto the inner surface of the contact lens body defining the lens cavity. Exposed hydrophilic groups such as alcohols located on the partially solubilized polymer particles of the insert material may weakly bind (e.g., via hydrogen bonding) to the exposed hydrophilic side chains of the lens material at the cavity boundaries.

Alternatively or in combination, the insert may be configured such that erosion of the insert material generates particles of one or more sizes. Varying the size of the channel dimension of the particles relative to the lens body can vary the diffusion characteristics of the insert material through the lens body. For example, particles having a size smaller than the channel size can easily pass through the channel to exit the lens. Particles having a size larger than the size of the channel cannot pass through the channel and can therefore be accommodated in the cavity. In many embodiments, the insert material erodes into a plurality of particles having variable particle sizes such that a portion of the particles can exit the cavity through the passage and a portion of the particles can be contained within the cavity. For example, erosion of an insert material comprising a first polymer and a second polymer may result in the formation of particles having a first size and particles having a second size, respectively. The particles having the first size may have a size smaller than the channel size, thus diffusing out of the cavity. The particles having the second size may be larger than the channels and thus remain in the cavity. The erodible insert material may, for example, comprise a first water soluble polymeric material and a second poorly soluble or insoluble polymeric material. The first water-soluble polymeric material may have a molecular weight less than that of the second polymeric material such that the second polymeric material remains within the cavity formed by dissolution of the first water-soluble polymeric material. The molecular weight of the first polymer may be such that dissolved particles of the first polymer are able to pass through the channels in the lens host material and diffuse out of the lens. The molecular weight of the second polymeric material may be such that particles of the dissolved or partially dissolved second polymer are prevented from passing through the channels. The particles remaining within the cavity may form a refractive index gradient as described herein.

The interface of the inner surface of the contact lens body may be configured in a number of ways to define a graded index of refraction provided having a refractive index gradient extending between the contact lens body and the liquid contained within the cavity. The material eroded from the insert within the chamber from the insert may include partially solubilized particles that are adsorbed to the surface of the contact lens material on the inner surface defining the cavity. For example, the adsorbed particles may comprise polymer particles comprising acetate groups. Alternatively or in combination, the eroded material may comprise water-insoluble particles that remain after the water-soluble material dissolves. Particles remaining within the chamber may be adsorbed onto the inner surface of the contact lens body defining the cavity. The plurality of particles may include a maximum size span exceeding about one-quarter of a wavelength of visible light so as to prevent scattering of light from the particles. For example, the plurality of particles may include a maximum size span of no more than about 150nm, and the maximum size span may be in a range of about 5nm to about 150 nm. For example, alternatively or in combination, the maximum distance excess may be in the range of about 10nm to about 100 nm. Particles within these ranges may increase the refractive index with an unacceptable amount of light scattering that is not perceptible to the wearer.

Alternatively or in combination, the gradient index of refraction may be provided by polymer side chains extending from the lens body into the cavity. The lens material may comprise, for example, HEMA. Hydrophilic side groups or side chains on HEMA can prevent hydrophobic acetate side chains of solubilized polymer from diffusing out of the cavity. Hydrophilic side groups on the polymer, such as PVA groups on a PVA-co-PVAc (PVA/Ac) polymer insert material, can be hydrophilically bound to HEMA at the cavity-lens body interface to provide a refractive index gradient as described herein. For example, the partially solubilized material within the chamber from the insert may comprise no more than about 10% by weight of the material within the chamber when the lens is worn.

The partially solubilized material within the cavity may comprise an amount sufficient to provide osmolality of the cavity. The luminal fluid can comprise an osmolality in the range of about 200 milliosmoles per liter (mOsmol/L) to about 290mOsmol/L, such as in the range of about 250mOsmol/L to about 290 mOsmol/L.

Fig. 10 shows a contact lens 100 having a single outer reservoir 116. The cavity 110 may be similarly shaped as described herein so as to include an inner optical chamber 114, a channel 118, and a peripheral reservoir 116. The cavity 110 may be formed by dissolving, eroding, degrading, or otherwise solubilizing an insert as described herein such that the shape of the cavity 110 corresponds to the shape of the insert. The insert may comprise an erodible material shaped to have an anterior surface and a posterior surface, each surface having a curvature corresponding to one or more surfaces of the contact lens 100. The cavity 110 may be formed between the front and rear surfaces of the lens body 120. The cavity 110 may be shaped to add negative power to the contact lens when light is refracted in the distance vision configuration. The anterior and posterior surfaces of the lens body 120 can each include a radius of curvature about the cavity 110 to provide distance vision correction in combination with the negative power of the cavity 110.

The insert may include a circular region that defines the inner optical chamber 114 after dissolution. The insert may include an outer region defining a peripheral reservoir 116. The insert may include an extension between the circular region and the outer region defining the channel 118. The inner optical chamber 114 may include a diameter 115 corresponding to the diameter of the circular region of the insert. The channel 118 may include a maximum dimension span 149 corresponding to a maximum dimension across the extension of the insert. The maximum dimensional span 149 of the channel 118 may be less than the diameter 115 of the inner optical chamber 114, and thus the maximum dimensional span of extension may be less than the diameter of the circular region of the insert. The lower chamber 116 may include a maximum dimension span 117 corresponding to a maximum dimension across the outer region of the insert. The maximum dimensional span 117 of the lower chamber 116 may be greater than the maximum dimension 149 of the channel 118, and the maximum dimensional span of the outer region may be greater than the maximum dimension of the extension.

The insert may include an optically smooth surface such that the formed cavity 110 includes an optically smooth inner anterior surface and an inner posterior surface to allow for vision correction as described herein. For example, the erodible lens insert may include an RMS roughness of no greater than about 50 nm. The RMS roughness of the insert may be greater depending on the difference between the refractive index of the liquid contained in the cavity and the refractive index of the lens body. The RMS roughness of the insert may be in the range of about 5nm to about 1000nm, for example in the range of about 10nm to about 500 nm. The inner surfaces of the cavity may be defined by upper and lower portions of the lens body extending across the optically used portion of the lens, and these surfaces may have a similar RMS roughness as the insert. For example, the inner surface of the cavity may have a surface roughness RMS value of about 50nm or less in order to provide clarity and allow vision correction.

The insert may have tapered edges to reduce astigmatism, refraction, or other aberrations that may be associated with abrupt changes in refractive index near the boundaries of the cavity 110 formed in the lens material 120.

During down gaze as described herein, expansion of the optical chamber 114 of the cavity 110 may occur through the action of the lower eyelid on the contact lens. When the lower eyelid engages the lower chamber 116 during downward gaze, fluid is transferred through the passage 118 to the inner optical chamber 114 to increase the curvature of the inner optical chamber 114 and provide optical power for near vision. The curvature of the inner optic chamber 114 may again decrease upon returning to primary fixation for distance vision. Fig. 10 illustrates various locations at which the lower eyelid may reside on the peripheral compartment 116 during a down gaze (shown in phantom) or a primary gaze (shown in solid). The lower eyelid may engage the peripheral chamber 116 to varying degrees during primary fixation. For example, during the minimum primary gaze 276, the lower eyelid may not engage the peripheral chamber 116 at all. The average primary gaze 274 may cause the lower eyelid to contact the lower portion of the peripheral chamber 116. The maximum primary gaze 272 may result in the lower eyelid contacting about half of the peripheral chamber 116. A similar change may be made in transitioning to a down gaze, where the smallest down gaze 286 engages the lower portion of the chamber 116, the average down gaze 284 engages about half of the chamber 116, and the largest down gaze 282 engages all or nearly all of the chamber 116. The transition between primary and down gaze and the corresponding change in lower eyelid position forces fluid from the peripheral reservoir 116 into the inner optical chamber 114 where the fluid may provide increased optical power for near vision.

As described herein, the cavity 110 can include a different index of refraction (also referred to herein as a refractive index) than the hydrogel material of the lens body 120 surrounding the cavity 110. The refractive index of the cavity may differ from the refractive index of the material of the lens body 120 by at least about 0.10. For example, the refractive index of the cavity may differ from the refractive index of the material of the lens body 120 by at least about 0.05. For example, the refractive index of the cavity may differ from the refractive index of the material of the lens body 120 by at least about 0.03. The difference in the refractive indices of the cavity 110 and the lens body 120 can provide optical power to the inner optical chamber 114.

The cavity 110 may include a refractive index similar to the hydrogel material of the lens body 120. The refractive index of the cavity may be within about 0.10 of the refractive index of the lens body material 120. For example, the refractive index of the cavity may be within about 0.05 of the refractive index of the lens body material 120. For example, the refractive index of the cavity may be within about 0.03 of the refractive index of the lens body material 120.

Fig. 11 shows a contact lens 100 with progressive peripheral reservoirs 116. The cavity 110 may be formed as described herein. Similar to the embodiment shown in fig. 10, the cavity 110 may include an inner optical chamber or central reservoir 114, a peripheral reservoir or lower chamber 116, and a channel 118 extending therebetween. The thickness 111 of the cavity 110 can be constant such that the thickness of the inner optical chamber 114 is approximately the same as the thickness of the peripheral reservoir 116 when the peripheral reservoir 116 is not engaged by the lower eyelid. The peripheral reservoir 116 may also include a primary gaze portion 270 configured to be engaged by the lower eyelid during distance vision and a downward gaze portion 280 configured to be engaged by the lower eyelid during near vision. When the eye is between a maximum primary gaze 272 (e.g., when looking straight forward at a distance) and a minimum primary gaze 276 (e.g., when looking at something lower at the ground at a distance), compression of the primary gaze portion 270 may provide a moderate amount of power change to the central reservoir 114. As gaze continues downward and moves closer, more of the peripheral reservoir 116, including the downward gaze portion 280, may be engaged to further increase the optical power in the inner optical portion 114. A measured amount of fluid may be contained within a portion of the peripheral reservoir 116 to provide a calculated response of the lens 100 to the wearer's needs. In this manner, the lens 100 can provide a range of optical powers suitable for a variety of eye positions, similar to a progressive lens in a spectacle function.

Fig. 12 shows a contact lens 100 having two peripheral reservoirs 116a, 116 b. The cavity 110 may be formed as described herein. The cavity 110 may include an inner optical chamber 114, a first outer chamber or peripheral reservoir 116a, a second outer chamber or peripheral reservoir 116b, and one or more channels 118 extending therebetween. The first outer chamber 116a may be located below the inner optical chamber 114. The second outer chamber 116b may be located below the inner optical chamber 114. First outer compartment 116a may be located below second outer compartment 116 b. The first outer chamber 116a and the second outer chamber 116b may each contain a quantity of fluid to provide near vision correction. Engagement of the first outer chamber 116a by the lower eyelid may provide a first amount of fluid to the inner optical chamber 114 and provide a medium vision correction. When looking further down, the second outer chamber 116b may also be engaged by the lower eyelid and the fluid of the second outer chamber 116b may combine with the fluid from the first outer chamber 116a and provide near vision correction to the inner optical chamber 114 of the lens 100. The amount of fluid in each outer chamber 116a, 116b can be measured to have a desired amount of intermediate and near vision correction. For example, the amount of fluid in first peripheral reservoir 116a may be such that the reservoir provides a 1D power increase to inner optical chamber 114 when compressed for intermediate vision. The fluid in the second peripheral reservoir 116b may have sufficient fluid to provide an additional 1D power increase, so that when the first outer chamber 116a and the second outer chamber 116b are compressed, the inner optical chamber 114 is provided a 2D total power increase for distance vision.

The cavity 110 of any of the embodiments described herein can include a fluid in equilibrium with an external liquid. For example, the cavity fluid may comprise one or more of water, saline, or tears. Water and other fluids may diffuse into and out of the contact lens body 120 from the outer surface of the contact lens body 120 to the cavity 110. When placed on the eye of a wearer, the chamber 110 may equilibrate with the tear fluid of the eye. For example, the liquid contained within the cavity may be at least partially released by the hydrogel lens body 120 onto the eye, e.g., to provide hydration. The liquid released by the chamber may be replaced by tears. The cavity may for example comprise a porous cavity.

The peripheral reservoir, when connected to the inner optical chamber, may be configured in a number of ways to provide accommodation. In many cases, the upper cover may help to adjust the lens. During down-gaze or strabismus, the upper cover may engage the fluid-filled cavity, thereby compressing the cavity and changing the shape of at least the inner optical chamber in order to change the optical power as described herein. The peripheral chamber may be connected to the inner optical chamber and sized and shaped in a number of ways, for example with an annular peripheral chamber extending around the inner optical chamber. Alternatively or in combination, the upper cover may engage an upper reservoir disposed above the inner optical chamber of the cavity. The peripheral reservoir described herein may be an upper or lower reservoir as desired by one of ordinary skill in the art to provide regulation as described herein. The upper reservoir may be coupled to the inner optical chamber through an upper channel to allow fluid to flow between the upper reservoir and the inner optical chamber. The cavity may include any combination of an inner optical chamber, an upper reservoir, and a lower reservoir. For example, the cavity may include an inner optical chamber coupled to the upper reservoir through an upper channel and to the lower reservoir through a channel as described herein. The cavity may alternatively comprise an inner optical chamber and an upper reservoir, without a lower reservoir. The engagement of the upper reservoir with the upper eyelid can be used to adjust the optical power of the lens in either the near-vision configuration or the distance-vision configuration in a manner substantially similar to the lower reservoir described herein.

As described herein, the insert may be configured such that erosion of the insert material generates particles of one or more sizes. The particles may be sized such that they may easily exit the lens through one or more channels of the lens body. The particles may have a size smaller than the size of the channels. One or more channels may facilitate removal of the insert material. In some cases, no residual insert material may remain in the cavity after the insert erodes.

The lens material can be configured (e.g., with one or more channels as described herein) such that particles or molecules (e.g., an inlay material or a therapeutic agent) having a radius of gyration within a predetermined range can diffuse through the lens material (e.g., a polymer) of the lens body. The radius of gyration of a molecule capable of diffusing through a polymer may be in the range of about 0nm to about 100nm, for example no greater than about 50nm or no greater than about 15 nm. The radius of gyration may be within a range defined between any two of the following values: 0nm, 5nm, 10nm, 15nm, 20nm, 25nm, 30nm, 40nm, 50nm, 60nm, 70nm, 80nm, 90nm and 100 nm.

The cavity may contain a therapeutic agent. As described herein, the therapeutic agent can be released to the eye through the lumen. The therapeutic agent may be selected from: anti-infective agents including, but not limited to, antibiotics, antivirals, and antifungals; anti-allergenic agents and mast cell stabilizers; steroidal and non-steroidal anti-inflammatory agents; cyclooxygenase inhibitors, including but not limited to Cox I and Cox II inhibitors; a combination of an anti-infective agent and an anti-inflammatory agent; a decongestant; anti-glaucoma agents including, but not limited to, adrenergic agents, beta-adrenergic blockers, alpha-adrenergic agonists, parasympathomimetic agents, cholinesterase inhibitors, carbonic anhydrase inhibitors, and prostaglandins; combinations of anti-glaucoma agents; an antioxidant; a nutritional supplement; drugs for the treatment of cystoid macular edema, including but not limited to non-steroidal anti-inflammatory agents; drugs for the treatment of ARMD, including but not limited to angiogenesis inhibitors and nutritional supplements; medicaments for the treatment of herpes infections and CMV ocular infections; drugs for the treatment of proliferative vitreoretinopathy including, but not limited to, antimetabolites and fibrinolytic agents; wound modulators, including but not limited to growth factors; an antimetabolite; neuroprotective drugs including, but not limited to, eliprodil; and angiostatic (angiostatic) steroids for use in the treatment of posterior segment diseases or conditions including, but not limited to, ARMD, CNV, retinopathy, retinitis, uveitis, macular edema, and glaucoma.

The therapeutic agent can include a molecular weight in the range of about 18 daltons to about 10 kD. The therapeutic agent may comprise a molecular weight within a range defined between any two of the following values: 10 dalton, 20 dalton, 50 dalton, 100 dalton, 200 dalton, 500 dalton, 1kD, 2kD, 3kD, 4kD, 5kD, 6kD, 7kD, 8kD, 9kD and 10 kD.

A cavity contact lens as described herein may be configured to provide a power change of at least +2 diopters (D), e.g., at least +3D, in response to a small increase in pressure so as to allow the contact lens to change shape in response to eyelid contact to correct presbyopia. The amount of internal pressure that increases the optical power by at least +2D may be in a range from about 10 pascals (Pa) to about 100Pa, such as in a range from about 20Pa to about 50 Pa. Defining a cavityThe thicknesses of the anterior and posterior lens portions may be sized as described herein to increase or decrease the amount of deflection of the lens in response to internal pressure generated by the eyelid. The modulus of the contact lens material may be increased or decreased to vary the amount of pressure increase to provide correction. The modulus of a hydrogel contact lens material as described herein can be in the range of about 0.2MPa to about 4MPa, for example, in the range of about 0.25MPa to about 2 MPa. In many cases, the modulus is related to the equilibrium water content, and the modulus may decrease with increasing amounts of hydration as described herein. The equilibrium water content may be in the range of about 25% to about 80%, for example in the range of about 30% to about 70% and in the range of about 40% to about 65%. The volume of the cavity may be about 0.25mm³To about 10mm³Within a range of, for example, about 0.5mm³To about 5mm³Within the range of (1). The internal pressure of the cavity may be measured by inserting a needle into the cavity and measuring the pressure using, for example, a manometer and other methods of measuring pressure known to those of ordinary skill in the art.

Table 1 lists examples of hydrogel materials, equilibrium water content, and modulus.

Although table 1 is provided as an example, other materials as described herein may also be configured to have a modulus and hydration amount as described herein.

Fig. 13A-13C illustrate a contact lens including a lumen 110 formed by etching an insert as described herein. The cavity 110 may be formed by dissolving, eroding, degrading, or otherwise solubilizing an insert as described herein such that the shape of the cavity 110 corresponds to the shape of the insert. The cavity 110 may be formed between the front and rear surfaces of the lens body 120. The insert may comprise an erodible material as described herein. When the insert is eroded, the low molecular weight or highly soluble components of the insert may readily diffuse through the lens body 120, while the high molecular weight or insoluble components of the insert may have reduced diffusion as described herein. For example, the insert may dissolve into particles having different sizes, where higher molecular weight particles cannot pass through the pores or channels in the lens body 120, while lower molecular weight particles readily diffuse out of the cavity 110. The cavity 110 may not include residual insert material as described herein. The cavity 110 may include residual insert material as described herein. Retention of residual insert material within cavity 110 may alter the osmotic pressure of cavity 110 and cause cavity 110 to swell as described herein. The amount of swelling or bulging of the cavity 110 can be controlled to achieve desired optical and/or physical properties of the lens 100. The amount of swelling or swelling of cavity 110 can be controlled by varying one or more of the temperature, the salinity of the surrounding solvent, the amount or type of sugar in the insert or solvent, the molecular size of the dissolved insert material, the dissolution rate of the insert material and its rate of water uptake, the solvent and insert dissolution conditions, or any combination thereof. For example, swelling can be moderated by increasing the heat of the solvent or increasing the salinity of the solvent. Alternatively or in combination, the channel size of the lens body material may be increased to allow larger or less soluble particles to diffuse through the lens, thereby changing the amount of insert material remaining in the cavity 110 and reducing the osmotic pressure of the cavity 110. The channel size may be varied as described herein, for example by varying the chemistry of the lens body formation. One or more channels or holes may be mechanically created in the lens body, for example using a syringe, needle, laser or other method suitable for creating holes. Alternatively or in combination, the one or more holes may be made by shaping the insert such that it leaves a hole in the lens body when eroded.

Fig. 13A shows a cross-sectional view of a contact lens 100 including an inner lumen 110 and a hole 310. Any of the contact lenses described herein may also include one or more holes or channels 310. The hole or channel 310 may comprise an opening in the lens body 120 that extends from the cavity 110 to the environment external to the lens 100. One or more holes 310 may be created by physically piercing the lens body 120. Alternatively or in combination, the one or more holes 310 may be created by chemically attacking the lens body 120 or by changing the chemical properties of the lens body 120 prior to UV curing. Alternatively or in combination, one or more holes 310 may be created by correspondingly shaped protrusions on the insert. The aperture 310 may be sized to facilitate release of the high molecular weight substance from the cavity, for example, to control, reduce, or prevent tenting of the lens 100 when the cavity 110 is formed after dissolution or erosion of the insert as described herein. The hole 310 may be positioned outside of the optical zone 170 to prevent visual aberrations. The hole 310 can be positioned within the optical zone 170.

Fig. 13B shows a cross-sectional view of the insert 140 including the protrusion 312. The channels 310 may be formed, for example, during curing of the lens 100. The insert 140 may be configured to form a corresponding hole in the lens after the insert 140 erodes to form the cavity. The insert 140 may be shaped substantially similarly to any of the inserts described herein, such that a cavity is formed within the lens body as the insert material erodes and diffuses out of the lens. The insert 140 may include a protrusion 312, the protrusion 312 extending beyond the upper surface 142 or the lower surface 144 of the insert 140 toward the outer surface of the lens. The protrusion 312 may be shaped such that it extends up to or beyond the surface of the lens after the lens is formed around the insert as described herein. The protrusion 312 may be located anywhere on the insert 140. As shown in fig. 13B, the protrusion 312 may be located, for example, on an outer edge of the insert. The protrusions 312 may be disposed on the insert

inner surfaces

142, 144 remote from the edges. The protrusions 312 may protrude toward the back surface of the lens, the front surface of the lens, or both. It should be understood that the protrusion 312 may be located on any portion of the insert 140 so as to form a hole in the lens body that extends into the cavity after the insert material is eroded (as shown in fig. 13A).

Fig. 13C shows a cross-sectional view of the contact lens 100 including the lumen 140 and the fill hole 314. After the lens has hydrated and the insert has eroded, the hole can be filled 314 to create a final lens 100 that includes an inner cavity 110 substantially similar to any lens as described herein. The hole may be filled 314 with any suitable material (e.g., the same or different material as used to form the lens) and then bonded or hardened to complete the lens body 120. For example, fill hole 314 may contain a lens body material that is injected into the hole by a syringe and UV cured to seal the hole. After insert erosion and cavity formation, the hole can be filled, plugged, sealed with a polymer including a contact lens polymer, welded, or otherwise closed using techniques known to those of ordinary skill in the art.

The inserts described herein may be sized and shaped in a number of ways. The insert may include a three-dimensional shape profile. The three-dimensional shape profile may include an outer boundary that defines an outer boundary of the cavity 110. The shape profile may include one or more curved surfaces that correspond to one or more surfaces of the contact lens (e.g., to the curvature of the lower base of the contact lens). The insert may be manufactured via casting, extrusion, molding, lamination, laser etching or ablation, or any other technique known to those skilled in the art. The insert may be formed by any combination of techniques to produce the desired three-dimensional profile.

The lens may be formed around an insert as described herein. The base layer of lens material may be created by adding a small amount of lens prepolymer into the lower mold cavity cup. The prepolymer material may be partially cured using UV light or other curing methods. The partially cured resin layer (e.g., the base layer or first portion) may be tacky or solid. An insert may be formed and/or placed over the partially cured resin layer in the lower mold cavity cup. The insert may be partially inserted or submerged in a partially cured base layer located in the lower mold cavity cup to secure the insert. The insert may be placed on the base layer by a robotic arm. Additional prepolymer may then be delivered to the mold, which may include the insert and partially cured resin, in an amount sufficient to create a top layer of lens material (e.g., to form the second portion) and complete lens formation. The robotic arm may deliver some or all of the additional prepolymer before, during, or after placing the insert on the substrate layer. The lens may then be fully polymerized by curing under, for example, UV light. The lens may then be hydrated and the insert may be dissolved to form a cavity having a desired shape within the lens body, and the dissolved insert material may diffuse out of the lens body as described herein. Alternatively or in combination, the insert may be formed on an intermediate layer of material, such as lens material or any other material as desired. An intermediate layer may be placed over the uncured or partially cured base layer of lens material before the top layer lens material is added and lens formation is completed.

After hydration and erosion of the insert to form the cavity, the contact lens body can include a first portion on a first side of the cavity that corresponds to a base layer of polymer poured as described herein. The contact lens body can also include a second portion on a second side of the cavity that corresponds to a top layer of polymer poured as described herein. The cavity may extend between the top layer and the bottom layer. The inner surfaces of the top and bottom layers, shaped by insert erosion, may define a cavity. The top and bottom layers may be bonded together remote from the cavity as described herein (e.g., where there is no insert). The cavity may comprise a fluid as described herein. The crosslinked polymer of the lens body exposed at the cavity edge may directly contact the fluid within the cavity. The interface at which the top layer and the bottom layer are bonded together may be undetectable. The interface at which the top layer and the bottom layer are bonded together may be detectable, for example, by dark field microscopy as known to those of ordinary skill in the art. For example, the lens may be bisected along a midline, and the interface between the two cured regions or layers may be visualized via light scattering using dark field microscopy.

The insert may be positioned during lens formation such that the cavity or a portion of the cavity (e.g., the inner optical chamber) is eccentric to the contact lens. The insert may be positioned during lens formation such that the cavity is concentric within the lens. The insert may be positioned and/or the cavity may be formed such that the cavity is concentric with the pupil when the lens is placed on the eye. The inner optical chamber can be positioned relative to the contact lens in a number of ways to accommodate anatomical changes in the eye. For example, the inner optical chamber may be positioned within a soft contact lens away from the center of the contact lens such that the inner optical chamber is concentric with the pupil. Alternatively, the inner optical chamber may be concentric with the contact lens. Those of ordinary skill in the art will appreciate that the pupil may be located away from the center of the cornea and that they may design the contact lens accordingly in accordance with embodiments disclosed herein. This approach allows the center of the inner optical chamber to be centered over the pupil when the soft contact lens is placed on the eye. The inner optical chamber may be concentric or eccentric within the soft contact lens (such as with respect to the center of the soft contact lens). The lens may be configured such that the optical zone is concentric or eccentric with respect to the center of the lens. The lens may be configured such that the optical zone is concentric or eccentric with respect to the pupil.

The diameter or maximum dimension of the optical zone and/or the inner optic chamber may span a size that matches the pupil based on physiological criteria. The diameter of the optical zone or inner optic chamber may be in the range of about 2.5mm to about 6mm, for example in the range of about 3mm to about 6 mm.

Erosion or dissolution of the insert can result in the formation of a cavity that includes an optically smooth surface through which light from the interior portion of the cavity passes to correct vision. The optically smooth surface may not include visually perceptible artifacts (e.g., less than about 0.1D) when worn by the patient. The optically smooth surface can have a wavefront distortion, as measured through the optically smooth surface, of about 0.3 microns or less, such as a wavefront distortion within a range defined between any two of the following values: about 0 microns, about 0.01 microns, about 0.025 microns, about 0.05 microns, about 0.075 microns, about 0.1 microns, about 0.125 microns, about 0.15 microns, about 0.175 microns, about 0.2 microns, about 0.225 microns, about 0.25 microns, about 0.275 microns, and about 0.3 microns. The optically smooth surface may have an RMS value of about 0.2 microns or less, such as an RMS value in a range defined between any two of the following values: about 0 microns, about 0.01 microns, about 0.025 microns, about 0.05 microns, about 0.075 microns, about 0.1 microns, about 0.125 microns, about 0.15 microns, about 0.175 microns, and about 0.2 microns. Erosion of the insert material may result in the formation of a cavity that includes residual surface structures corresponding to the surface structures of the insert. The residual surface structure may comprise a three-dimensional pattern left by a three-dimensional patterning on the surface of the insert. Alternatively or in combination, the residual surface structure may comprise residual insert material. The inner surface of the cavity may have an RMS value in a range defined between any two of the following values: about 5nm, about 10nm, about 15nm, about 25nm, about 50nm, about 100nm, about 200nm, about 300nm, about 400nm, about 500nm, about 600nm, about 700nm, about 800nm, about 900nm, and about 1000 nm. The inner surface of the cavity may have an RMS value of about 50nm or less.

When placed on the eye, the shape-changing portion of the lens (e.g., the inner optic chamber and/or the peripheral reservoir as described herein) used to correct vision can have an RMS optical path difference aberration of about 0.4 microns or less in the distance vision configuration. The RMS optical path difference may be measured on the eye using Hartmann-Shack wavefront aberration measurements or other techniques known to those of ordinary skill in the art. When placed on the eye, the shape-changing portion of the lens for correcting vision (e.g., the inner optical chamber and/or the peripheral reservoir as described herein) can have an RMS optical path difference aberration of about 0.4 microns or less in the near vision configuration. The RMS optical path difference aberration may, for example, be within a range defined between any two of the following values: about 0 microns, about 0.01 microns, about 0.025 microns, about 0.05 microns, about 0.075 microns, about 0.1 microns, about 0.125 microns, about 0.15 microns, about 0.175 microns, about 0.2 microns, about 0.225 microns, about 0.25 microns, about 0.275 microns, about 0.3 microns, about 0.325 microns, about 0.35 microns, about 0.375 microns, and about 0.4 microns.

The insert may comprise any of the insert materials described herein. The insert 140 may have a thickness in a range from about 0.5 microns to about 100 microns. The insert 140 may have a thickness within a range bounded by any two numbers from table 2, such as within a range of about 0.5 microns to about 10 microns, or within a range of about 4 microns to about 60 microns. The insert may have a thickness greater than about 100 microns. The insert may have a thickness in a range defined between any two of the following values: about 0.5 microns, about 15 microns, about 75 microns, about 100 microns, about 150 microns, and about 200 microns.

Table 2 shows the range of values that can be taken for the insert thickness.

Table 2 insert thickness values.

The insert may comprise a material capable of deforming at room temperature without breaking. The insert may comprise a material capable of bending to a radius of curvature in the range of about 5mm to about 1m, for example in a range defined between any two of the following values: about 5mm, about 10mm, about 25mm, about 50mm, about 100mm, about 200mm, about 300mm, about 400mm, about 500mm, about 600mm, about 700mm, about 800mm, about 900mm, and about 1000 mm. The insert may optionally comprise an elastomeric material. The insert may comprise a flexible, non-brittle material.

Factors that affect the dissolution of the intercalate may include the molecular size of the dissolved intercalate material, the dissolution rate of the intercalate material and its rate of water uptake, the conditions under which the solvent and the intercalate dissolve, or any combination thereof. The insert may be dissolved (dissolve), eroded, degraded or solubilized (dissolglize) in the lens cavity with or without swelling.

The insert may be formed of any material that is capable of being suitably dissolved, eroded, degraded or solubilized by an aqueous solution, alcohol or other solvent, or any combination thereof. The insert material may include one or more low molecular weight components that are capable of diffusing through the lens host material upon hydration, exposure to an aqueous solution, exposure to an alcohol-based solution, exposure to an organic solvent, or any combination thereof. The insert material may include one or more components having a reduced ability to diffuse through the lens body as described herein. The insert material may be photo-curable. The insert material may be moldable. The insert material may be extrudable. The insert material may comprise a sugar such as fructose, galactose, glucose, glyceraldehyde, lactose, maltose, ribose, sucrose or any other mono-, di-or polysaccharide such as cellulose or methyl cellulose. The insert material may include sugar alcohols such as arabitol, sorbitol, D-sorbitol, erythritol, fucitol, galactitol, glycerol, iditol, inositol, isomalt, lactitol, maltotetratol, maltoseAlcohols, maltotriose, mannitol, inositol, polyglucitol, ribitol, sorbitol, threitol, xylitol or any other sugar alcohol. The sugar-based insert material may include a low molecular weight and is therefore beneficial when reduced bloom is desired as described herein. The insert material may include a salt, such as sodium chloride, sodium carbonate, potassium chloride, or any other salt. The intercalate material may comprise dimethyl sulfoxide (DMSO), N-vinyl pyrrolidone (NVP), polyethylene glycol (PEG), sodium polymethacrylate, METHOCEL^TME6 or any material described herein. The insert material may comprise polyvinyl alcohol (PVA), and the polymer chain of the PVA may comprise vinyl acetate (VAc) groups interspersed between vinyl alcohol groups as described herein. Copolymers of PVA with PVAc may be produced by partial hydrolysis of polyvinyl acetate (PVAc) to PVA so as to have pendant groups mixed along the polymer chain comprising acetate and alcohol groups. The insert material may be selected to reduce deformation of the lens before, during, or after insert removal. The insert material may be any combination of the materials described herein.

The insert material may include one or more low molecular weight components. The insert material may include a molecular weight in a range of about 1g/mol (grams per mole) to about 50,000g/mol, or in a range between any two weights therebetween. The insert material may, for example, include a molecular weight in the range of about 50g/mol to about 10,000g/mol, such as in the range of about 50g/mol to about 5,000g/mol, or in the range of about 50g/mol to about 1000 g/mol. For example, the insert material may include sodium chloride having a molecular weight of 58.44 g/mol. The insert material may comprise glucose having a molecular weight of 180 g/mol. The insert material may comprise isomalt having a molecular weight of 334 g/mol. The insert material may comprise sucrose having a molecular weight of 342 g/mol.

The insert material may include a molecular weight in the range of about 50g/mol to about 100,000g/mol, or in a range limited by any two numbers therebetween. The insert material may comprise a molecular weight within a range defined between any two of the following values: 50g/mol, 100g/mol, 500g/mol, 1,000g/mol, 5,000g/mol, 10,000g/mol, 25,000g/mol, 50,000g/mol, and 100,000 g/mol.

The insert material may comprise PVA or PVA/Ac as described herein. The molecular weight of the PVA or PVA/Ac may be in the range of about 50 daltons (e.g., g/mol) to about 100,000 daltons, or within a range limited by any two numbers therebetween. The insert material may comprise PVA or PVA/Ac having a molecular weight within a range defined between any two of the following values: 50 daltons, 100 daltons, 500 daltons, 1,000 daltons, 5,000 daltons, 10,000 daltons, 25,000 daltons, 50,000 daltons and 100,000 daltons. The insert material may include PVA or PVA/Ac having a molecular weight of less than about 13,000 daltons.

Erodible inserts as described herein may be configured in a number of ways and may include sufficient strength to facilitate handling of the insert in a self-supporting configuration (e.g., when the insert is placed on a partially cured contact lens material). The insert may comprise a combination of materials and thicknesses as disclosed herein so as to allow the insert to bend from a substantially planar configuration to a radius of curvature in a range of about 5mm to about 1 m. The insert may be resilient and capable of returning substantially to an initial profile to be bent, for example at least about 90% from a deflected profile to the initial profile. The insert may include additives as described herein to promote flexibility. Although the insert may be optically smooth to an RMS roughness of about 50nm or less, for example, the insert may include a greater amount of roughness without affecting the optical quality of the lens, such as when the fluid of the optical cavity has an index of refraction within about 0.1 times that of the fully hydrated contact lens material defining the cavity. Although the roughness and surface texture of the insert may be imparted on the contact lens material defining the cavity after erosion of the insert, this level of such texture and roughness may be controlled by manufacturing the insert such that the surface texture of the insert material imparted on the lens cavity does not provide perceptible optical artifacts to the user or reduce vision in many cases.

The lens 100 may be formed in a number of ways. The lenses may also be manufactured via casting, extrusion, molding, lamination, or any other technique known to those skilled in the art. The lens 100 may be formed by molding or the like. The lens 100 may be formed in any shape or size as desired. The material of the lens may be, for example, a polymer that forms a hydrogel in water or an aqueous solution. The lens material may include acofilcon A, acofilcon B, alfafilcon A, altrafilcon A, atlafilcon A, balafilcon A, bufilcon A, comfilcon A, crofilcon, deltafilcon A, dimefilcon A, droxifilcon A, efrofilcon A, enfilcon, epsilon filcon A, etafilcon A, focfilcon A, galafilcon A, heficon A, hefiicon B, hefilcon C, hilafilcon A, hilafilcon B, hiofilcon A, hiofilcon B, hiofilcon A, hisifilcon B, hisafilconfilcon D, isifilcon, lidilcon A, lisafilcon B, lotafilconfilcon B, lotafilcon A, theofilcon A, flavofilcon B, flavofilcon A, flavofilcon B, flavofilcon A, telfilcon B, flavofilcon A, telfilcon B, telfilcon A, telfilcon B, telfilcon A, telfilcon B, telfilcon A, telfilcon B, telfilcon A, telfilcon B, telfilcon A, telfilcon B. One or more lens materials may be used to form the lens. For example, the base layer may comprise a different lens material than the top layer.

Some or all of the lens material may be partially or fully cured before, during or after the manufacturing process.

The insert material may be extracted from the lens body by exposure to an aqueous solution, an alcohol-based solution, an organic solvent, or any combination thereof. The insert material may be extracted from the lens body, for example, by saline. The insert material may be extracted from the lens body by an organic solvent such as an alcohol (e.g. ethanol), an ether (e.g. a cyclic ether such as tetrahydrofuran), etc. The solvent may be miscible in water or an aqueous solution. The insert material may be extracted from the lens body by a combination of saline and an organic solvent (e.g., a water-miscible organic solvent such as isopropanol, methanol, tetrahydrofuran, or ethanol). The insert material may be extracted from the lens body at room temperature or at a temperature above room temperature. For example, the insert material may be extracted at a temperature in the range of about 20 ℃ to about 80 ℃ or at any temperature in the range of any two temperatures therebetween. The extraction of the inlay material may be performed at a temperature in the range of about 25 ℃ to about 60 ℃. The insert material may be extracted at any temperature desired to achieve cavity formation. The insert material may be extracted from the lens body by any solvent or solution known to those of ordinary skill in the art to be compatible with the lens material. Removal of the insert material from the lens body to form the cavity may be assisted by circulating an extraction solution or solvent around the lens body.

Fig. 14 shows a contact lens 100 that includes an inner cavity 110. The cavity 110 may be substantially similar to any of the cavities described herein. For example, the cavity 110 may include an inner optical chamber 114 and one or more lower chambers (not shown) as described herein. The inner optical chamber 114 may flex in response to compression of one or more lower chambers as described herein. The deflection of the inner optical chamber 114 may provide optical correction as described herein. The flexing of the inner optical chamber 114 can provide increased optical power to provide near vision correction as described herein. The lens front side 104 can flex with the flexing of the inner optical chamber 114. The flexing of the lens front side 104 can provide optical correction, such as increased optical power, as the lens front side 104 is flexed forward by compression of the one or more lower chambers. The lens front side 104 may be flexed to provide a uniform optical correction, such as spherically flexed. The lens front side 104 may flex to provide a non-uniform optical correction, such as a non-spherical flexure. The lens front side 104 may have a multifocal profile 320 having regions with different optical powers. As an example, there may be a first region 322 having a high optical power (e.g., 3D), a second region 324 having an intermediate optical power (e.g., 2D), and a third region 326 having a low optical power (e.g., 1D). These numbers are intended as examples only, and one skilled in the art will appreciate that lens 100 may be configured to accommodate many possible values of optical power as desired. The multifocal profile 320 may be composed of different regions or may be continuous. The multifocal profile 320 may have different regions with different optical powers. The multifocal profile 320 may have a continuously varying region of optical power. The lens 100 may include a multifocal profile 320 in a near vision configuration. Alternatively or in combination, the lens 100 may include a multifocal profile 320 in a distance vision configuration.

Figure 15 shows a cross-sectional view of a hydrogel contact lens 100 including a lumen 110. The cavity 110 may include residual insert material as described herein. The residual insert material may be cross-linked within the cavity 110, for example, during UV curing of the lens body around the insert prior to hydration. The residual insert material may be cross-linked within the cavity 110 by a chemical cross-linking agent before, during, or after hydration. The cross-linked material 268 may be free-floating or cross-linked with the exposed lens polymer material at one or more locations. For example, the cross-linked material 268 may extend across the cavity 110 from the front edge 133 of the cavity 110 to the back edge or substrate 132 of the cavity 110. Cross-linked material 268 may extend into cavity 110 from one point along leading edge 133 to another point along leading edge 133. Cross-linked material 268 may extend into cavity 110 from one point along trailing edge 132 to another point along trailing edge 132. The cross-linked material 268 may form a network of cross-linked polymer chains within the cavity 110 that are connected to the leading edge 133, the trailing edge 132, any other surface defining the cavity 110, or any combination thereof, or it may not be connected to the lens body surface defining the cavity 110. The insert material may include, for example, any material that crosslinks when exposed to UV light. The insert material may include a UV blocking or absorbing material to alter the degree or location of crosslinking. The insert may, for example, be encapsulated in or include a UV blocker. The insert material may be selected to create a desired cross-linking arrangement for optical, structural or functional purposes.

In some embodiments, it may be desirable to prevent cross-linking of the residual inlay material. The insert material may include, for example, any material that does not crosslink when exposed to UV light. Alternatively or in combination, the insert 140 may be encapsulated in, mixed with, manufactured from, or otherwise created using a UV blocking or absorbing material in order to prevent cross-linking of the insert material during photo-curing of the lens body 120.

Fig. 16 shows a contact lens 100 having a cavity 110 configured for delivery of a therapeutic agent to the eye of a wearer. The cavity 110 may contain a therapeutic agent 330. Therapeutic agent 330 may include any of the drugs or therapeutic agents described herein. Therapeutic agent 330 may include a variety of therapeutic agents, such as a mixture of therapeutic agents or any number of therapeutic agents as desired. Therapeutic agent 330 may be introduced into lumen 110 in a number of ways. For example, an insert that erodes to form a cavity may include the therapeutic agent 330. Alternatively or in combination, the therapeutic agent 330 can be a coating on the insert. The therapeutic agent 330 may remain in the cavity after the insert is dissolved. Alternatively or in combination, the therapeutic agent 330 can be introduced into the cavity 110 after the insert erodes or via a solution external to the storage lens 100. The external solution can be an aqueous solution 204 containing a therapeutic agent 330 such that when the lumen 110 and the external storage solution reach equilibrium, the therapeutic agent 330 diffuses through the lens body 120 into the lumen 110. The storage solution may have a concentration, temperature, composition, or any comparable parameter or combination of parameters such that the diffusion rate may be controlled to load the chamber 110 with a desired amount of therapeutic agent 330. Therapeutic agent 330 may also be introduced into lumen 110 by any technique known to those skilled in the art.

When the lens 100 is worn, the therapeutic agent 330 can be delivered to the eye via diffusion. The therapeutic agent 330 can diffuse to the eye through the posterior side 106 of the lens 100 or through the anterior side of the lens. The back side 106 of the lens 100 may act as a rate control structure. For example, the back side 106 of the lens 100 may include a thickness 107. Thickness 107 can be sized to control the diffusion rate 332 of therapeutic agent 330 through the posterior side 106 of lens 100 onto the surface of the eye. Alternatively or in combination, the aperture of the lens body 120 may be configured to control the diffusion rate 332 of the therapeutic agent 330 through the posterior side 106 of the lens 100. The molecular weight and/or size of the therapeutic agent can affect the rate of diffusion through the posterior side 105. Therapeutic agent 330 may have a molecular weight in the range of, for example, about 18 kilodaltons to about 10 kilodaltons. In many embodiments, the molecular weight of the therapeutic agent does not exceed the molecular weight of the insert material so as to allow the therapeutic agent to diffuse out of the lumen and onto the eye when worn. For example, the therapeutic agent may include water for moisturizing the eye and other materials such as surfactants for retaining water. Although reference is made to the rear side of the lens providing the rate control structure, the front side of the lens may be similarly configured.

Any range of molecular weights can be combined with any range or size, any range of thicknesses, or any combination thereof in order to achieve a desired rate of diffusion of therapeutic agent 330 out of the cavity 110, through the lens posterior side 106, and onto the eye. For example, for a given molecular weight of therapeutic agent 330, thickness 107 can be varied to achieve a desired rate of release of the therapeutic agent.

The therapeutic amount of therapeutic agent 330 can cause a change in the refractive index of the cavity. The change in refractive index can be in the range of about 0.01 to about 0.02 such that vision is not significantly altered by the presence of the therapeutic agent 330. Alternatively or in combination, there may be a second cavity formed by a second insert outside the optical zone. The second cavity can contain a therapeutic agent 330 such that the therapeutic agent 330 remains outside of the optical zone of the lens. Such an approach may be a useful way to maintain the therapeutic agent delivery capabilities of the lens without affecting vision, particularly for those types of therapeutic agents that may be used at high concentrations or that may affect the refractive index, reducing vision beyond acceptable levels. The cavity in the optical zone, a second cavity outside the optical zone, or both cavities can contain one or more therapeutic agents 330. The lumens may contain different therapeutic agents 330 or the same therapeutic agent 300. The lumens may contain the same concentration of therapeutic agent 330 or different concentrations of therapeutic agent 330. It should be understood that lens 100 may include any number of lumens of any size as desired to deliver any number or concentration of therapeutic agents to any desired location on the eye as desired. For example, the lumen may be positioned so as to deliver the therapeutic agent directly to the site of injury or infection. One or more lumens may be positioned so as to generate a therapeutic agent concentration gradient across the surface of the eye.

Therapeutic agent 330 may include a half-life of about 1 day to about 7 days to allow introduction of therapeutic agent 330 into lumen 110 from an external storage solution and/or to achieve a desired release of the active compound or therapeutic agent 330 onto the eye. Alternatively or in combination, the therapeutic agent may comprise a solid to provide a substantially constant release rate while the solid remains present on the lens.

Fig. 17 shows a contact lens 100 having a cavity 110 near a posterior lens surface 136 configured for delivery of a therapeutic agent to the eye of a wearer. Placement of the cavity 110 near the back lens surface 136 may be useful to achieve the desired diffusion behavior. Placement of the cavity 110 near the back lens surface 136 may be useful to achieve the desired refractive behavior, and the placement may be located outside of the optical zone in such a manner. Lumen 110 may be continuous with one or more other lumens in the lens configured for delivery of therapeutic agents, for assisting vision, or for any other purpose disclosed herein. The cavity 110 may contain a therapeutic agent 330. Therapeutic agent 330 may include any of the drugs or therapeutic agents described herein. The therapeutic agent 330 may include a plurality of drugs, such as a mixture of drugs or any number of drugs as desired. Therapeutic agent 330 may be introduced into lumen 110 in a number of ways. For example, an insert that erodes to form a cavity may include the therapeutic agent 330. Alternatively or in combination, the therapeutic agent 330 can be a coating on the insert. The therapeutic agent 330 may remain in the cavity after the insert is dissolved. Alternatively or in combination, the therapeutic agent 330 can be introduced into the cavity 110 after the insert erodes or via a solution external to the storage lens 100. The external solution can be an aqueous solution 204 containing a therapeutic agent 330 such that when the lumen 110 and the external storage solution reach equilibrium, the therapeutic agent 330 diffuses through the lens body 120 into the lumen 110. The storage solution may have a concentration, temperature, composition, or any comparable parameter such that the diffusion rate may be controlled to load the chamber 110 with a desired amount of therapeutic agent 330. Therapeutic agent 330 may also be introduced into lumen 110 by any technique known to those skilled in the art. When the lens 100 is worn, the therapeutic agent 330 can be delivered to the eye via diffusion. The therapeutic agent 330 can diffuse through the posterior side 106 of the lens 100 to the eye. The back side 106 of the lens 100 may act as a rate control structure. For example, the back side 106 of the lens 100 may include a thickness 107. Thickness 107 can be varied to control the rate 332 of diffusion of therapeutic agent 330 through the posterior side 106 of lens 100 onto the surface of the eye.

Fig. 18 shows a contact lens 100 having a cavity 110 near the anterior lens surface 137 configured for delivery of a therapeutic agent to the eye of a wearer. Placement of the cavity 110 near the front lens surface 137 may be useful to achieve the desired diffusion behavior. Placement of the cavity 110 near the back lens surface 136 may be useful to achieve the desired refractive behavior, and the placement may be located outside of the optical zone in such a manner. Lumen 110 may be continuous with one or more other lumens in the lens configured for delivery of therapeutic agents, for assisting vision, or for any other purpose disclosed herein. The cavity 110 may contain a therapeutic agent 330. Therapeutic agent 330 may include any of the drugs or therapeutic agents described herein. The therapeutic agent 330 may include a plurality of drugs, such as a mixture of drugs or any number of drugs as desired. Therapeutic agent 330 may be introduced into lumen 110 in a number of ways. For example, an insert that erodes to form a cavity may include the therapeutic agent 330. Alternatively or in combination, the therapeutic agent 330 can be a coating on the insert. The therapeutic agent 330 may remain in the cavity after the insert is dissolved. Alternatively or in combination, the therapeutic agent 330 can be introduced into the cavity 110 after the insert erodes or via a solution external to the storage lens 100. The external solution can be an aqueous solution 204 containing a therapeutic agent 330 such that when the lumen 110 and the external storage solution reach equilibrium, the therapeutic agent 330 diffuses through the lens body 120 into the lumen 110. The storage solution may have a concentration, temperature, composition, or any comparable parameter such that the diffusion rate may be controlled to load the chamber 110 with a desired amount of therapeutic agent 330. Therapeutic agent 330 may also be introduced into lumen 110 by any technique known to those skilled in the art. When the lens 100 is worn, the therapeutic agent 330 can be delivered to the eye via diffusion. The therapeutic agent 330 can diffuse through the posterior side 106 of the lens 100 to the eye. The back side 106 of the lens 100 may act as a rate control structure. For example, the back side 106 of the lens 100 may include a thickness 107. Thickness 107 can be varied to control the rate 332 of diffusion of therapeutic agent 330 through the posterior side 106 of lens 100 onto the surface of the eye.

Fig. 19 shows a contact lens 100 having a cavity 110 outside of the optical zone 170 configured for delivery of a therapeutic agent to the eye of a wearer. The cavity 110 may contain a therapeutic agent 330. Therapeutic agent 330 may include any of the drugs or therapeutic agents described herein. The therapeutic agent 330 may include a plurality of drugs, such as a mixture of drugs or any number of drugs as desired. Therapeutic agent 330 may be introduced into lumen 110 in a number of ways. For example, an insert that erodes to form a cavity may include the therapeutic agent 330. Alternatively or in combination, the therapeutic agent 330 can be a coating on the insert. The therapeutic agent 330 may remain in the cavity after the insert is dissolved. Alternatively or in combination, the therapeutic agent 330 can be introduced into the cavity 110 after the insert erodes or via a solution external to the storage lens 100. The external solution can be an aqueous solution 204 containing a therapeutic agent 330 such that when the lumen 110 and the external storage solution reach equilibrium, the therapeutic agent 330 diffuses through the lens body 120 into the lumen 110. The storage solution may have a concentration, temperature, composition, or any comparable parameter such that the diffusion rate may be controlled to load the chamber 110 with a desired amount of therapeutic agent 330. Therapeutic agent 330 may also be introduced into lumen 110 by any technique known to those skilled in the art. When the lens 100 is worn, the therapeutic agent 330 can be delivered to the eye via diffusion. The therapeutic agent 330 can diffuse through the posterior side 106 of the lens 100 to the eye. The back side 106 of the lens 100 may act as a rate control structure. For example, the back side 106 of the lens 100 may include a thickness 107. Thickness 107 can be varied to control the rate 332 of diffusion of therapeutic agent 330 through the posterior side 106 of lens 100 onto the surface of the eye.

The posterior side of the lens may include a thickness defined between the posterior surface of the contact lens body and the posterior surface of the internal cavity in a range of about 10 microns to about 200 microns, or in a range bounded by any two thicknesses therebetween. The back side of the lens may include a thickness in a range of about 10 microns to about 150 microns, 10 microns to about 100 microns, about 10 microns to about 50 microns, or about 10 microns to about 25 microns. The back side of the lens may include a thickness in a range of about 25 microns to about 200 microns, about 25 microns to about 150 microns, about 25 microns to about 100 microns, or about 25 microns to about 50 microns. The back side of the lens may include a thickness in a range of about 50 microns to about 200 microns, about 50 microns to about 150 microns, about 50 microns to about 100 microns. The back side of the lens may include a thickness in a range of about 100 microns to about 200 microns, about 100 microns to about 150 microns. The back side of the lens may include a thickness in a range of about 150 microns to about 200 microns.

The anterior side of the lens may include a thickness defined between the anterior surface of the contact lens body and the anterior surface of the internal cavity in a range of about 10 microns to about 200 microns, or in a range bounded by any two thicknesses therebetween. The anterior side of the lens may include a thickness in a range of about 10 microns to about 150 microns, 10 microns to about 100 microns, about 10 microns to about 50 microns, or about 10 microns to about 25 microns. The anterior side of the lens may include a thickness in a range of about 25 microns to about 200 microns, about 25 microns to about 150 microns, about 25 microns to about 100 microns, or about 25 microns to about 50 microns. The anterior side of the lens may include a thickness in a range of about 50 microns to about 200 microns, about 50 microns to about 150 microns, about 50 microns to about 100 microns. The front side of the lens may include a thickness in a range of about 100 microns to about 200 microns, about 100 microns to about 150 microns. The front side of the lens may include a thickness in a range of about 150 microns to about 200 microns.

The front thickness of the lens may be less than the back thickness of the lens. The posterior thickness of the lens may be less than the anterior thickness of the lens. The front thickness of the lens may be substantially the same as the back thickness of the lens. The front side of the lens may have a uniform thickness or a non-uniform thickness. The back side of the lens may have a uniform thickness or a non-uniform thickness.

The lens may include a total thickness defined between the anterior surface of the contact lens body and the posterior surface of the contact lens body in a range of about 20 microns to about 400 microns, or in a range bounded by any two thicknesses therebetween. The total thickness of the lens may range from about 50 microns to about 400 microns, from about 80 microns to about 350 microns, from about 80 microns to about 250 microns, from about 100 microns to about 300 microns, from about 100 microns to about 400 microns, from about 200 microns to about 300 microns, from about 300 microns to about 400 microns.

The cavity may include a thickness defined between a front surface of the cavity and a rear surface of the cavity in a range of about 0.5 microns to about 200 microns, or in a range bounded by any two thicknesses therebetween. The cavity may include a thickness in a range of about 5 microns to about 150 microns, about 15 microns to about 100 microns, about 15 microns to about 50 microns, about 25 microns to about 200 microns, about 50 microns to about 100 microns.

Experiment of

The inventors performed bench tests and calculations to develop an adjustable contact lens. The development of adjustable contact lenses with embedded cavities utilized simulation and analysis approaches based on COMSOL, MATHCAD, SOLIDWORKS, and MATLAB. Table 3 shows the design parameters used in example 1.

TABLE 3 Adjustable contact lens size (EXAMPLE 1)

It was found that the cavity exhibited a power of-0.70D, since the refractive index of the cavity was less than that of the matrix. The power of the entire lens was simulated to be-0.93D.

Table 4 shows the design parameters used in example 2.

TABLE 4 Adjustable contact lens size (example 2).

It was found that the cavity exhibited a power of 0.0D, since the refractive index of the cavity was less than that of the matrix. The power of the entire lens was simulated to be-0.23D.

The lens power is modeled as a function of the depth of the cavity within the lens and as a function of the back radius of curvature of the cavity.

Fig. 20 shows simulation results of lens power as a function of the back radius of curvature of the cavity according to an embodiment.

The spherical lens power (measured in D) is simulated relative to the posterior radius of curvature (roc) of the cavity (measured in mm). Roc values from 8.7mm to 6.9mm vary the spherical lens power between-1D to 1.25D. The lens power strongly depends on the back curvature of the cavity. The curvature can be controlled by providing the insert as a curved membrane having a particular radius of curvature.

Fig. 21 shows simulation results of lens power as a function of cavity position within a lens according to an embodiment.

Spherical lens power is modeled as a function of the cavity position (distance measured in um) in the lens relative to the front lens surface. It is simulated that a cavity position between 100um and 1900um gives a spherical lens power between-0.25D and-0.2D. The lens power was found to be not very sensitive to the depth of the cavity in the lens, which provides some margin to the tolerance of the z-axis placement of the cavity within the lens mold cavity.

Further assume that the hydrogel constituting the lens has a tensile modulus of 1MPa, a bulk modulus of saline of 2.08GPA, and a density of 1000Kg/m³. Swelling simulations were performed for eyelid tensions of 10Pa, 50Pa, 250Pa and 1000 Pa.

Table 5 provides the results of the simulation.

The sag profile obtained by the simulation shows that the enhanced sag profile is substantially spherical, reaching a positive power of 3.0D at eyelid pressure of 50 Pa.

Several lenses were cast for each of example 1 and example 2. The insert is called

GA grade biocompatible, soluble, uncrosslinked polyvinyl alcohol. Of this particular grade

Can be dissolved in cold water and can be used for treating,and pair

Studies of dissolution in water at room temperature show that the polymer film dissolves without initial swelling, which is beneficial because swelling of the insert prior to its dissolution may lead to cavity expansion, which may lead to rupture. Other biocompatible water-soluble polymers that may be used according to embodiments include polyvinyl alcohol, polyvinyl acetate, polyethylene oxide, propylene oxide, copolymers of ethylene oxide and propylene oxide (pluronic acid), polyvinylpyrrolidone, polyethyleneimine, polyacrylamide, and polysaccharides.

The insert may be made of a single material or a blend of polymers having different dissolution rates so as to control the rate of cavity formation by dissolving the material comprising the insert. The solute may be dissolved or incorporated into the material comprising the insert prior to forming the insert. The solute may have a molecular weight such that diffusion of the solute through the cavity boundary and permeation through the lens body may be controlled.

The insert may be formed using methods including thermoforming, compression molding, or solution casting. The surface of the insert may be coated to modify and control the diffusion of solvents and other solutes across the boundaries of the lumen. For example, the insert may be coated with a solution of a crosslinking agent or a photo-curing catalyst to develop a gradient in crosslink density and cure rate that begins at the surface of the insert.

In one embodiment, the adjustable contact lens is cast from a hydrogel having a water content of 32% formed by photopolymerization and crosslinking of a zero expansion formulation. Alternative embodiments may include lenses cast from hydrogels having water contents in the range of about 28% to 65%. The polymerized lens material may comprise one or more monomers or oligomers, homopolymers, or low expansion polymers. Other polymers may be used depending on the embodiment, including silicone hydrogel copolymers. The curing method is not limited to photopolymerization and may include any suitable method for the selected contact lens polymer and may include a catalyst or reactant.

FIGS. 22A-22B illustrate a casting cup for casting an adjustable contact lens, according to an embodiment. In this embodiment, the monomer is placed in a mold cavity formed as shown in fig. 22A-22B. The insert described herein has the benefit that previously known molds can also be used to cast lenses comprising an internal cavity.

The lower mold forming the front surface of the lens is held by a jig. A small amount (about 10uL) of monomer was delivered from a syringe under nitrogen into a lower cup that was lowered down the center of the mold by a clamp. The resin is partially cured and then the insert held at the tip of the vacuum clamp is lowered vertically along the center of the lower mold into the resin layer in the lower cup. The jig is then raised and then used to lower the syringe filled with additional monomer in order to deliver the remaining monomer needed to form the lens. The syringe is raised back after the monomer is delivered and the upper mold is lowered along the same vertical (z) axis using the same fixture. The two molds were gently engaged and squeezed shut. The design of the die rim and its diameter is critical to ensure that the die forms a closed cavity by press fitting without disturbing the monomer surface or forming air bubbles.

The mold assembly was then cured under long wave UV light (390nm) until polymerization was complete. The mold is then opened and the lens adhered to the lower mold is then immersed in saline and sonicated to demold the lens. The demolded lenses were hydrated for a period of 2-6 hours and then washed with NaOH (0.01M) diluted in deionized water for a period of 2-6 hours. The lens was then placed back in saline and hydrated by immersion in saline for a period of 6-24 hours. The saline solution is replenished at least once more before hydration is complete.

Fig. 23A-23B illustrate the progression of hydration and progressive dissolution of the insert 140 to form the cavity 110.

Fig. 23A shows contact lens 100 after two hours of hydration in 0.9% saline and 1.5 hours of sonication. Contact lens 100 has begun to hydrate and insert 140 remains visible within the lens.

Fig. 23B shows contact lens 100 after overnight hydration, whereby lens 100 has become fully hydrated and insert 140 has dissolved to form cavity 110.

Fig. 24 shows a fully hydrated soft contact lens 100 under bright field microscopy. After the insert gradually dissolves, hydrated lens 100 includes an insert cavity 110 that remains where insert 140 was.

Table 6 reports data on the thickness of layers in an adjustable contact lens with an embedded cavity.

TABLE 6 lens thickness distribution.

The target thickness of the adjustable contact lens is 200 microns, so there is a satisfactory consistency between the target thickness and the actual thickness.

Fig. 25 shows an adjustable soft contact lens on the eye comprising a cavity (example 3). By passing

The GA grade insert dissolves and diffuses through the lens body material comprising HEMA to form a cavity. The cavity is shaped similarly to the embodiment of fig. 12, with an inner optical chamber 114, a first outer chamber 116a, a second outer chamber 116b, and one or more channels (not labeled) therebetween, as shown in fig. 12. The boundaries of the

chambers

114, 116a, 116b of the cavity are barely visible on the eye, indicating that the lens has a high level of transparency and optical quality after hydration and dissolution of the insert material.

Fig. 26 shows an adjustable soft contact lens on the eye comprising a dyed cavity (example 4). The lens is formed similarly to the lens in fig. 25, except that dye has been added to the chamber to increase contrast and allow direct visualization of the chamber on the eye. Some artifacts of the molding process can be seen (such as bubbles near the peripheral chambers 116a, 116 b). Based on the teachings provided herein, one of ordinary skill in the art can construct a lens without such artifacts, while the image is a structure provided to show a contact lens that is not typically visible. The central reservoir 114 and outer chambers 116a, 166b are properly positioned on the eye to provide accommodation as a function of gaze. The inner (central) reservoir 114 is located above the optical center portion of the eye. Rapid repeated blinks did not interfere with the position of the chamber relative to the optical portion of the eye, indicating that the lens was stably positioned on the surface of the eye. The first outer (peripheral) compartment 116a and the second outer compartment 116b are located above the lower eyelid of the eye and therefore do not provide any added optical power to the inner optic compartment 114 when the eye and contact lens are in the distance vision configuration. The change in gaze may engage the outer chambers 116a, 116b with the lower eyelid to provide intermediate and near vision correction as described herein.

Fig. 27 shows a lens power measurement test on an adjustable soft contact lens having an inflated inner cavity as described herein. The lens 100 is formed similarly to the lenses in embodiments 3 and 4 described previously. Light in the form of a grid of points passes through the lens 100 in order to determine the power of the lens 100 at various locations of the lens body. The spot size inside the lens is compared to the spot size outside the lens, which corresponds to a power of 0D, to determine the power change of the lens. The ratio of spot size and the spacing of the spots from each other is directly related to the optical power. For example, if the spot size inside the lens is twice the spot size outside the lens, the power of the lens is 2D. If the spot size inside the lens is half the spot size outside the lens, the power of the lens is-2D. The aspherical spot represents the refraction in the lens, which may be related to the astigmatism of the lens.

The lens 100 includes regions of different optical power. The center of the lens includes an optical zone 170 as described herein. The optical zone 170 is substantially circular and has a diameter of about 6 mm. Surrounding the optical zone 170 is a transition zone 172 that appears as a point of flattening that may indicate refraction. The next annular zone comprises an outer near vision zone 176, which may include refractive ballast to stabilize the lens, such as with the rotationally stabilized contact lens design of fig. 6. The outer edge of the lens 102 includes a blend zone 174 that loses focus and power compared to the central region of the lens. The spot size in the outer near vision zone 176 is about half the spot size outside the lens, indicating that the outer near vision zone 176 has an optical power of about-2D. Points within the optical zone 170 are similarly spaced from points outside the lens and correspond to an optical power of about 0D, which is about +2D compared to points in the outer near vision zone 176. A power of about 0D with inflation would allow near vision for the wearer with myopia. Thus, the lens with the inflated inner optic chamber is a multifocal lens having both near and distance vision zones and a transition zone 172 extending therebetween and a well-formed central optic zone 170. As the compartment shrinks, the optical power of the inner optical zone will become approximately-2D and provide distance vision correction for the central optical zone 170. Although the lenses are shown with reference to spherical lenses to correct for spherical refractive power of-2D, other lenses having other optical powers and astigmatic corrections can be made and tested as described herein.

The lens includes a small amount of astigmatism or refraction in the transition region 172. The refraction in the transition zone may be related to the rate of change of the radius of curvature (roc) of the different lens regions. The ballast lens design may provide a reduced rate of change of roc resulting in a reduced difference between the radial and sagittal curvatures moving radially outward from the center of the lens. The lens may be substantially radially symmetric as defined by the ballasted back curve and the insert for forming the cavity. The insert may, for example, have tapered edges to reduce the rate of change of roc and prevent the formation of refraction near the boundary of the cavity. Alternatively or in combination, the amount of refraction in the lens can be reduced by forming a graded index having a refractive index gradient extending between the cavity and the lens body as described herein. The refractive index gradient may suppress refraction associated with the abrupt change in refractive index at the cavity boundary.

Fig. 28A-28B show the adjustable soft contact lens of fig. 26 on the eye. Optical Coherence Tomography (OCT) was used to generate cross-sectional images of the lens and eye surface along the lines indicated in fig. 28A. Figure 28B shows an OCT cross-section of contact lens 100 with the thickness of various portions of lens 100 highlighted. The cavity 110 is formed with a thickness of about 220um, which corresponds to the thickness of the insert used to form the cavity 110. The cavity 110 is defined as the space between the back side 106 of the lens 100 and the front side 104 of the lens 100. In this embodiment, the front side 104 of the lens 100 is about 330um thick and the back side 106 of the lens 100 is about 100um thick. Lens 100 is positioned over the cornea of eye 290, which has a thickness of about 550 um. In many embodiments, the thickness of the front hydrogel layer 104 of the lens 100 may be different than the thickness of the back hydrogel layer 106 of the lens 100. As shown in fig. 28B, the thickness of the anterior surface 104 of the lens may be greater than the thickness of the posterior surface 106 of the lens, for example, to inhibit deformation of the anterior surface of the lens when the contact lens is in a near vision configuration for presbyopia correction and the inner optical chamber of the cavity is inflated to increase optical power.

The thickness of the anterior surface 104 of the lens may be less than the thickness of the posterior surface 106 of the lens, for example, to facilitate flexing of the anterior surface 104 of the lens when the contact lens is in a near vision configuration for presbyopia correction and the inner optical chamber of the cavity 110 is inflated to increase optical power. The thickness of the anterior surface 104 of the lens may be less than the thickness of the posterior surface 106 of the lens such that expansion of the inner optical chamber of the cavity 110 causes deflection of the anterior surface 104 and the posterior surface 106, wherein upon expansion, the anterior surface 104 deflects beyond the posterior surface 106 to correct presbyopia. In many embodiments, the front side 104 of the lens is at least about 50 microns thick. In many embodiments, the front side 104 of the lens is no greater than about 100 microns thick. In many embodiments, the thickness of the back side 106 of the lens is at least about 100 microns. In many embodiments, the thickness of the back side 106 of the lens is no greater than about 200 microns.

Fig. 29 shows an adjustable soft contact lens on the eye comprising a cavity with a central ridge (example 5). The lens was formed similarly to the lenses in embodiment 3 and embodiment 4. Use of

A cavity is formed within the lens material containing HEMA. When the lens is hydrated, the lens is,

the insert is degraded and allows the soluble component to diffuse out of the lens body to form a cavity.

A copolymer comprising PVA. As described herein, depending on the degree and efficiency of hydrolysis of PVAc, PVA polymerizesThe polymer chain may retain an amount of residual acetate, for example in the range of about 1% to about 20%. Solubilized

At least a portion of the material may comprise vinyl groups that include acetates that are only partially soluble or insoluble and that are unable to diffuse through the pores of the HEMA lens body as described herein. When water flows into the cavity during hydration, residual insert material may cause a change in osmotic pressure in the cavity and expansion of the cavity, creating a bulge 290 as shown in example 5. The degree of tenting and osmotic pressure of the cavity can be adjusted by varying the acetate content in the PVA insert material. As described herein, the pressure of the cavity is relieved after about 1-2 days and can contribute to the refractive index gradient within the cavity, which can in turn contribute to the low refraction in the optical zone observed in fig. 27. As described herein, the insert material can be configured in a number of ways so as to provide a limited amount of swelling that inhibits swelling of the contact lens body defining the cavity during hydration and provides a suitable osmolarity of the cavity as described herein.

Fig. 30A-30B show the adjustable soft contact lens of fig. 29 on the eye. OCT is used to generate a cross-sectional image of the lens and eye surface along the line indicated in figure 30A. FIG. 30B shows an OCT cross-section of contact lens 100, highlighting the thickness of various portions of lens 100. The cavity 110 is formed with a thickness of about 220um, which corresponds to the thickness of the insert used to form the cavity 110. In this embodiment, the hydration period is intracavity, as described herein

The degradation increases the osmotic pressure of the inner optical chamber 114 and creates an osmotic pressure bulge of about 2mm thickness between the inner anterior surface 104 and the inner posterior surface 106 of the lens defining the cavity. The protuberances 290 stretch the lens front side 104 to about 20um thick near the thickest portion of the protuberances 290. This osmotic pressure relieves itself after 1-2 days, and the protuberances 290 retract to form having a low profile in the optical zone as described hereinRefractive index gradient cavity 110.

Several lenses were cast for each of example 3, example 4 and example 5. As described herein, the insert of each lens is referred to as

GA grade biocompatible soluble uncrosslinked polyvinyl alcohol. Of GA grade

Is a copolymer of vinyl alcohol and vinyl acetate and dissolves rapidly in cold water. Other biocompatible water-soluble polymers that may be used in accordance with embodiments include polyvinyl alcohol, polyvinyl acetate, copolymers of vinyl acetate and vinyl alcohol (e.g., poly [ (vinyl alcohol) -co- (vinyl acetate)]Or PVA/Ac), polyethylene oxide, propylene oxide, polyethylene glycol (PEG) having a molecular weight ranging from about 600g/mol to about 6000g/mol, copolymers of ethylene oxide and propylene oxide (pluronic acid), polyvinylpyrrolidone, polyethyleneimine, polyacrylamide, and polysaccharides. The water soluble insert may comprise a polyacrylate or polymethacrylate or copolymers thereof of the hydrophilic ionic type. Carboxylate groups pendant from the polymer may be ionized to bind with divalent or trivalent metal ions as counter ions, and these carboxylate groups may also be used to form a water-soluble polymer film. For example, depending on the ionization constant of the polymer-bound carboxylate groups, the metal ions can form ionic crosslinks that are sensitive to water and open up in water at a particular pH. As shown in fig. 12, the insert is shaped to create a cavity having an inner optical chamber, a first outer chamber, a second chamber, and one or more channels therebetween.

Fig. 31 shows a method of manufacturing a contact lens comprising a cavity according to an embodiment.

At step 2301, an erodible insert material may be provided. The erodible insert may be any of the insert materials previously described herein. The insert material may be formulated such that the insert may be present after being subjected to a thermal or UV curing process.

At step 2302, an insert material may be shaped to form an insert. The forming may include one or more optional steps, which may include heating (step 2303), stamping a shape from the insert material (step 2304), or providing curvature to the insert material (step 2305). For example, the desired shape may be stamped from a solid insert material and then heated while placed on a sphere having the desired lens base curve.

At step 2306, a small amount of lens prepolymer may be provided to the mold.

At step 2307, the prepolymer can be partially cured to form a bed of inserts.

At step 2308, a shaped solid erodible insert may be provided to the partially cured polymer.

At step 2309, the insert may optionally be secured to the partially cured polymer substrate by providing a drop of polymer to the insert and rapidly curing it in place.

At step 2310, additional prepolymer may be added to the mold to encapsulate the insert.

At step 2311, a lens may be shaped. Shaping the lens may include one or more steps, including cutting (step 2312) or molding (step 2313).

At step 2314, the lens may be hydrated.

At step 2315, the insert may be dissolved.

Hydration of the lens and degradation of the insert material may occur at different rates. For example, the lens material may hydrate faster than the insert material dissolves, thereby limiting expansion of the lens material (e.g., HEMA) into the cavity. Alternatively, the lens material may be flared outward to form a full-sized contact lens with little or no aberrations or damage to the cavity.

At step 2316, at least a portion of the insert material may diffuse through the lens body.

At step 2317, at least a portion of the insert material may remain within the cavity.

The insert material may, for example, comprise a material as described herein

Degradation of a material into its components can generate multiple polymer chains. At least a portion of the polymer chains may comprise an acetate ester that is hydrophobic and water insoluble. At least a portion of the polymer chains may include an alcohol that is hydrophilic and soluble in water. The dissolved components can diffuse through the hydrophilic lens material (e.g., HEMA) and be released from the cavity. When the concentration of acetate on each polymer chain is sufficiently high, e.g., above about 3% or 4% of pendant groups, the hydrophobic moieties on the polymer chains may be repelled by HEMA, resulting in residual amounts of the inlay material remaining in the cavity after lens hydration. When water flows into the lumen during hydration, residual insert material may cause a change in osmotic pressure in the lumen and expansion of the lumen. When the chamber is balanced with the HEMA, the pressure of the chamber can be relieved. The composition of the insert material can be varied to adjust the osmotic pressure of the cavity and/or the amount of residual material, for example, by varying the ratio of hydrophobic side groups to hydrophilic side groups of the polymer.

The insert may, for example, comprise a substance, such as a cross-linking agent, that may be used to alter the properties of the cavity. The density of the lens material may be varied according to the desired lens characteristics. The crosslink density of the lens material may be varied according to desired lens characteristics, for example to vary the aperture of the lens.

While the above steps illustrate methods of using an erodible insert to provide a contact lens with a cavity according to embodiments, those of ordinary skill in the art will appreciate numerous variations based on the teachings described herein. These steps may be performed in a different order. Steps may be added or deleted. Some steps may include sub-steps. These steps may be repeated to provide a contact lens or insert as described herein.

Fig. 32-33 illustrate the diffusion of low molecular weight dye out of the lens cavity. The lens 100 including the cavity 110 is formed as described herein and a low molecular weight dye is added to the cavity 110 to act as a substitute for the insert material in order to monitor the effect of the molecular size of the insert material on the rate of diffusion/extraction out of the lens body. The dye had a molecular weight of 242g/mol and was water-soluble. The lens containing the dye was immersed in the PBS hydration solution 340 and diffusion from the chamber was monitored by observing the color change of the solution surrounding the lens. Fig. 32 shows the lens 100 prior to immersion in the extraction or hydration solution 340 (e.g., at hour 0). Due to the presence of the dye, the cavity 110 appears dark. Fig. 33 shows the lens 100 after incubation in the extraction solution 340 for 24 hours. The dye diffuses out of the chamber 110 into the extraction solution 340, so the extraction solution 340 appears darker in fig. 33 than in fig. 32 due to the presence of the dye.

Fig. 34A-34F illustrate the diffusion of two different molecular weight dyes out of the lens cavity. The lenses 100a and 100B are filled with low molecular weight dyes in their cavities 110a and 110B, respectively, and the diffusion rates are qualitatively assessed by monitoring the color of the extraction solution 340 as described in fig. 34A-34B. FIGS. 34A-34C show a lens 100a containing a dye having a molecular weight of 242g/mol within the cavity 110 a. Fig. 34A shows the lens before incubation in PBS extraction solution 340. Fig. 34B and 34C show the lens 100a and extraction solution 340 after 5 hours of incubation. As the dye diffuses through the lens body and into the extraction solution, the extraction solution 340, as well as the lens body, has begun to deepen. FIGS. 34D-34F show a lens 100a containing a dye having a molecular weight of 872g/mol within the cavity 110 b. Fig. 34D shows the lens prior to incubation in PBS extraction solution 340. Fig. 34E and 34F show the lens 100b and extraction solution 340 after 5 hours of incubation. Most of the dye remained in the cavity 110b after 5 hours, and thus the extraction solution 340 had little color change. The results of fig. 34A-34F show that the size of the insert material can affect the rate at which the insert material can diffuse out of the lens body to form the cavity. Alternatively or in combination, the extraction of the insert material from the lens may depend on the permeability of the lens material, the polarity of the lens material, and/or the polarity of the insert material.

Extraction of the inlay material may be aided by varying the composition, temperature, and/or movement of the extraction solution 340. Some possible combinations of these parameters were tested. A brine concentration of between about 0.9% to about 25% and a temperature of between about 25 ℃ to about 65 ℃ were tested. The brine was tested in combination with isopropanol and other organic solvents. In some experiments, extraction was performed by changing the brine and organic solvent at different time intervals to create a chemical pumping effect to extract the insert material from the cavity. A medium pressure circulator was used in multiple experiments with different solvents and different temperatures to further aid in the extraction of the inlay material. It was found that organic solvents in combination with saline can accelerate the extraction process of the intercalate material compared to saline alone. The use of solvent recycling can improve the extraction process. Extraction at elevated temperatures in combination with solvent circulation provides accelerated extraction.

A number of potential insert materials were tested for their ability to readily diffuse out of the lens body, including PEG (multiple different molecular weights), Methocel at 50,000g/mol^TME6 (cellulose-like material), sodium polymethacrylate (multiple different molecular weights), PVA/Ac (multiple different molecular weights), sugars (including isomalt, sucrose and glucose) and salts (including sodium chloride). The ability of the insert material to form a film-like insert (e.g., by spreading a thin layer of hydrated insert material and allowing it to form a dry film by evaporation), the ability to diffuse through the lens (by measuring the concentration of the insert material in the extraction solution), and/or flexibility were tested. The cavity of the monitoring lens is formed with or without a ridge formation. In some cases, it may be desirable to form an insert material that readily diffuses out of the lens body without forming a thin, flexible film-like insert that bulges.

Fig. 35A-35C show sucrose films produced using an cast-free melt process. Heated liquid sucrose is spread on a flexible surface, such as a silicone sheet, using applicator blades at elevated temperatures. The sucrose was cooled to form a 22um thick film sheet, which could be used to form an insert of the desired shape and size. The sucrose film was removed from the silicone sheet by bending the sheet to release the film and allow it to be removed. Fig. 35A shows a sucrose insert membrane 140a on a silicone sheet. Fig. 35B shows the removal of the sucrose membrane 140a of fig. 35A from a silicone sheet by means of a thinner removal tool 350. Fig. 35C shows the sucrose membrane 140a of fig. 35A after removal from the silicone sheet to form a self-supporting sucrose membrane 140 a. The experiments using solvent film casting were not successful in film formation.

Fig. 36A-36C illustrate the flexibility of various sugar-based insert films. Figure 36A shows the flexibility of a 22um sucrose film. Fig. 36B shows the flexibility of 55um glucose membranes. Fig. 36C shows the flexibility of a 50um isomalt film. Each sugar film is relatively flexible and capable of bending or flexing. The flexibility of the sugar film may depend on the moisture and relative humidity of the surrounding environment. The flexibility of the sugar film can be varied to provide a disposable insert so that the insert can be sized and shaped as desired.

Fig. 36D-36F show the cavity formation results for lenses containing various sugar-based inserts. Backlighting is applied in order to better visualize the cavity 110 within the lens 100. Each lens 100 is hydrated to dissolve the insert and form a cavity 110. Fig. 36D shows a cavity 110 formed by a 22um sucrose insert after 24 hours of hydration with an extraction solution as described herein. A cavity 110 is formed without significant swelling or bulging. Fig. 36E shows the cavity 110 formed by the 55um glucose insert after 24 hours of hydration. A cavity 110 is formed with little apparent swelling. Fig. 36F shows the cavity 110 formed by a 50um isomalt insert after 24 hours of hydration. A cavity 110 is formed with a small amount of significant and acceptable swelling. The concentration of the material in the extraction material can be measured in a number of ways, such as by liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), gas chromatography-flame ionization detection (GC-FID), and other methods of detecting the material known to those of ordinary skill in the art.

Fig. 37A shows a 200um thick insert 140 made of sodium chloride. The insert 140 is formed by compressing fine sodium chloride solids using a 2 ton press at high load. In an early experiment, as shown in fig. 37B, a salt sheet was formed with a tool having a patterned surface that left an embossed pattern 360 on the inner walls of the lens cavity 110. A piece of stainless steel with a mirror surface was used to overcome the problem of lens patterning. Fig. 37B-37D show the results of the formation of cavities 110 for three different lenses 100 containing 200um sodium chloride inserts. Backlighting is applied in order to better visualize the cavity 110 within the lens 100. After 24 hours of hydration, a cavity 140 was formed without significant ridge formation. Fig. 37C shows the lens 100 with the cavity 110 without the bump. Fig. 37D shows a lens 100 having a cavity 110 that includes an entrained bubble 370 defect. Other salts, such as less crystalline salts, may also be used as the insert material.

Using Methocel^TMExperiments with E6 show that Methocel^TME6 can be formed as a film insert. Lenses cast around the insert were hydrated and larger elevations were observed after hydration. The insert material did not diffuse out of the cavity efficiently, probably due to its high molecular weight of 50,000 g/mol.

Experiments using sodium polymethacrylate showed different abilities to form thin film inserts. The higher molecular weight sodium polymethacrylate of 12,000g/mol formed a good film, whereas the lower molecular weight sodium polymethacrylate of 1,200g/mol crystallized during evaporation without forming a film-like insert. Lenses cast around 12,000g/mol sodium polymethacrylate formed larger bumps after a short period of about 1-2 hours of hydration. The affinity of sodium polymethacrylate for water may lead to ridge formation, indicating that an inlay material with a high water content can be avoided if ridges are not desired.

Experiments were performed using PVA/Ac at 12,000g/mol and 6,000g/mol and formed good film inserts. Lenses cast around 12,000g/mol insert formed a ridge after 24 hours of hydration and no PVA/Ac material was detected in the extraction solution, saline or isopropanol tested. Lenses cast around 6,000g/mol inserts had little ridge formation.

In another experiment, 6000g/mol of a mixture of 70% PVA/Ac and 30% polyethylene glycol was dissolved in water and spread on a flexible surface for drying. PEG was added to act as a plasticizer. The water is evaporated to form a film-like insert material. The insert material is highly flexible, non-tacky and strong. The insert is not brittle and has good tensile strength. The insert can be lifted without breaking, as a self-supporting insert supporting its own weight. The insert is flexible, having a radius of curvature of about 7 mm.

Additional experiments may be performed with dark field microscopy to detect an interface between a first portion of a contact lens formed by partial polymerization and a second portion of a bonded contact lens formed by additional polymerization of the first portion, the additional polymerization being performed in the presence of a precursor material that polymerizes to form the second portion. For example, an insert as described herein may be placed on the first portion after the first portion has been partially polymerized such that the first portion is sufficiently tacky to support the insert. Additional precursor material can be placed in a mold having a first portion supporting an insert as described herein and cured to form a second portion of the contact lens bonded to the first portion of the contact lens remote from the insert. For example, the first portion and the second portion may be formed from the same type of precursor material. The insert may then be eroded as described herein. The hydrated contact lens can be observed with dark field microscopy as known in the art, and the interface of the first portion bound to the second portion detected. Although the interface may be detected by dark field microscopy in many cases, the interface does not produce artifacts that are perceptible to the user, and the lens appears transparent under normal bright field microscopy. In at least some cases, the structure imparted on the inner surface of the contact lens body by the insert can also be detected by dark field microscopy. The contact lens may be optically sectioned, or the contact lens may be sectioned by mechanical cutting, and the interface may be observed with dark field microscopy.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. A soft contact lens for correcting vision in an eye, comprising:

a hydrogel contact lens body comprising water and a crosslinked polymer, wherein the contact lens body defines a cavity comprising a fluid, and wherein the crosslinked polymer allows water to diffuse into and out of the contact lens body so as to diffuse from an outer surface of the contact lens body to the cavity, and wherein the cavity is shaped to correct vision when in equilibrium with tear fluid of the eye.

2. The soft contact lens of claim 1, wherein the contact lens body and the cavity are configured together to increase optical power by at least 2D and an internal pressure increase of 20 pascals (Pa) to 50Pa, and wherein the cavity comprises a volume containing the fluid, the volume being at 0.5mm³To 5mm³Wherein the contact lens body comprises a modulus in the range of 0.25MPa to 2MPa, wherein the hydrogel material of the contact lens body comprises an equilibrium water content in the range of 30% to 70%.

3. The soft contact lens of claim 1 wherein the lens body comprises an inner surface defining the cavity, the inner surface comprising an inner surface structure defined by eroding material from within the cavity.

4. The soft contact lens of claim 1, wherein the lens body comprises a first portion on a first side of the cavity and a second portion on a second side of the cavity, the cavity extending between the first portion and the second portion, the first portion bonded to the second portion distal from the cavity to contain a fluid within the cavity.

5. A soft contact lens as in claim 1, wherein said cross-linked polymer is in direct contact with the liquid of said cavity.

6. The soft contact lens of claim 1, wherein the cross-linked polymer comprises sufficient rigidity to retain the shape of an insert dissolved from within the lens body to form the cavity.

7. A soft contact lens as in claim 1, wherein the cavity comprises a dissolved material having a molecular weight in the range of 3 kilodaltons to 7 kilodaltons, and wherein the dissolved material is capable of diffusing through the crosslinked polymer of the contact lens body.

8. The soft contact lens of claim 7, wherein the dissolving material comprises dissolving a material forming an insert of the cavity.

9. The soft contact lens of claim 8, wherein the cavity comprises a shape profile corresponding to the dissolved insert.

10. The soft contact lens of claim 1, wherein the cavity comprises an optical portion configured to correct vision of the eye and a lower portion fluidly coupled to the optical portion, and wherein the optical portion is configured to provide near vision correction when an eyelid engages the lower portion.

11. The soft contact lens of claim 10, wherein the cross-linked polymer comprises a sufficient amount of cross-linking to retain fluid in the optical portion when the lower portion engages an eyelid to correct near vision of the eye.

12. The soft contact lens of claim 10, wherein the lens body comprises one or more hinge portions coupled to the optic portion and the lower portion.

13. The soft contact lens of claim 1, wherein the cavity comprises one or more internal structures formed of an erodible material.

14. The soft contact lens of claim 1, wherein the crosslinked polymer comprises a hydrogel.

15. The soft contact lens of claim 1, wherein the cross-linked polymer comprises a homogeneous polymer.

16. A soft contact lens as in claim 1, wherein said crosslinked polymer comprises a homopolymer.

17. A soft contact lens as in claim 1, wherein the cross-linked polymer comprises channels sized to allow water to diffuse between the cavity and the exterior of the contact lens body and inhibit bacteria from entering the cavity from the exterior of the contact lens body.

18. A soft contact lens as in claim 1, wherein the cross-linked polymer allows diffusion of molecules having a radius of gyration of no greater than 50nm through the cross-linked polymer of the contact lens body.

19. The soft contact lens of claim 18, wherein the cross-linked polymer allows diffusion of molecules having a radius of gyration of no greater than 15nm through the cross-linked polymer of the contact lens body.

20. A soft contact lens as in claim 1, wherein the cavity comprises a dissolved material having a molecular weight in the range of 3 kilodaltons to 10 kilodaltons, and wherein the dissolved material is capable of diffusing through the crosslinked polymer of the contact lens body.

21. The soft contact lens of claim 1, wherein the cavity comprises a volume in the range of 1uL to 5 uL.

22. The soft contact lens of claim 1, wherein the fluid comprises an index of refraction in the range of 1.31 to 1.37, and wherein the contact lens body comprises an index of refraction in the range of 1.37 to 1.48.

23. The soft contact lens of claim 1 wherein the contact lens body has an anterior side having an anterior thickness defined between the anterior surface of the contact lens body and the anterior surface of the cavity, and wherein the contact lens body has a posterior side having a posterior thickness defined between the posterior surface of the contact lens body and the posterior surface of the cavity.

24. The soft contact lens of claim 23, wherein the anterior thickness is less than the posterior thickness.

25. The soft contact lens of claim 23, wherein the anterior thickness ranges between 10 microns and 25 microns, between 50 microns and 100 microns, or between 150 microns and 200 microns.

26. The soft contact lens of claim 23, wherein the posterior thickness ranges between 10 microns and 100 microns.

27. The soft contact lens of claim 23, wherein the thickness of the cavity from its anterior surface to its posterior surface ranges between 0.5 microns and 15 microns, or between 50 microns and 100 microns.

28. The soft contact lens of claim 23, wherein the thickness of the lens body from its anterior surface to its posterior surface is in the range of 80 microns to 250 microns.

29. The soft contact lens of claim 1, wherein the shape changing portion of the soft contact lens for correcting vision when placed on an eye has an RMS optical path difference aberration in the distance vision configuration of 0.4 microns or less.

30. The soft contact lens of claim 1, wherein an inner surface of the cross-linked polymer defining the cavity comprises a shape profile corresponding to a solid material dissolved to form the cavity.

31. The soft contact lens of claim 30, wherein the inner surface of the cross-linked polymer defining the cavity comprises a structure corresponding to a solid material dissolved to form the cavity.

32. The soft contact lens of claim 30, wherein the inner surface of the cavity comprises an optically smooth surface over an interior portion of the cavity through which light passes to correct vision.

33. The soft contact lens of claim 32, wherein the optically smooth surface has a wavefront distortion of 0.3 microns or less as measured through the optically smooth surface.

34. The soft contact lens of claim 32 wherein the optically smooth surface does not contain visually perceptible artifacts when worn by a patient.

35. The soft contact lens of claim 32, wherein the optically smooth surface has an RMS value of 0.2 microns or less.

36. The soft contact lens of claim 30, wherein the inner surface of the cavity comprises residual surface structures from dissolving the solid material forming the cavity.

37. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value of 50nm or less.

38. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 5nm and 10nm, between 15nm and 300nm, or between 500nm and 1000 nm.

39. The soft contact lens of claim 4, wherein the interface of the first portion bonded to the second portion is detectable by dark field microscopy.

40. The soft contact lens of claim 23, wherein the anterior thickness ranges between 10 microns and 50 microns.

41. The soft contact lens of claim 23, wherein the anterior thickness ranges between 10 microns and 100 microns.

42. The soft contact lens of claim 23, wherein the anterior thickness ranges between 10 microns and 150 microns.

43. The soft contact lens of claim 23, wherein the anterior thickness ranges between 10 microns and 200 microns.

44. The soft contact lens of claim 23, wherein the anterior thickness ranges between 25 microns and 100 microns.

45. The soft contact lens of claim 23, wherein the anterior thickness ranges between 25 microns and 150 microns.

46. The soft contact lens of claim 23, wherein the anterior thickness ranges between 25 microns and 200 microns.

47. The soft contact lens of claim 23, wherein the anterior thickness ranges between 50 microns and 200 microns.

48. The soft contact lens of claim 23, wherein the anterior thickness ranges between 25 microns and 50 microns.

49. The soft contact lens of claim 23, wherein the anterior thickness ranges between 100 microns and 150 microns.

50. The soft contact lens of claim 23, wherein the anterior thickness ranges between 50 microns and 150 microns.

51. The soft contact lens of claim 23, wherein the anterior thickness ranges between 100 microns and 200 microns.

52. The soft contact lens of claim 23, wherein the posterior thickness ranges between 10 microns and 200 microns.

53. The soft contact lens of claim 23, wherein the posterior thickness ranges between 100 microns and 200 microns.

54. The soft contact lens of claim 23, wherein the thickness of the cavity from its anterior surface to its posterior surface ranges between 0.5 microns and 50 microns.

55. The soft contact lens of claim 23, wherein the thickness of the cavity from its anterior surface to its posterior surface ranges between 0.5 microns and 100 microns.

56. The soft contact lens of claim 23, wherein the thickness of the cavity from its anterior surface to its posterior surface ranges between 15 microns and 100 microns.

57. The soft contact lens of claim 23, wherein the thickness of the cavity from its anterior surface to its posterior surface ranges between 15 microns and 50 microns.

58. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 5nm and 15 nm.

59. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 15nm and 500 nm.

60. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 5nm and 300 nm.

61. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 300nm and 1000 nm.

62. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 5nm and 500 nm.

63. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 5nm and 1000 nm.

64. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 10nm and 300 nm.

65. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 10nm and 500 nm.

66. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 10nm and 1000 nm.

67. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 15nm and 1000 nm.

68. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 10nm and 15 nm.

69. The soft contact lens of claim 30, wherein the inner surface of the cavity has an RMS value in a range between 300nm and 500 nm.